Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Senior Quality Auditor is a member of the Quality Assurance Team reporting directly to the Sr Manager, Quality Auditing. They conduct internal audits ensuring compliance with all applicable cGMP regulations, processes, systems and provisions of the Quality System. They host and manage regulatory authority and client inspections. They serve as a technical expert within the Quality Auditing department. They are responsible for results in terms of quality system conformance to regulations and Simtra quality policies.

The responsibilities:

 Performs internal audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Ensures that audit schedules are produced and communicated in a timely fashion. Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines. This includes review of updated GMP regulations and current FDA and outside of US requirements and incorporation into internal programs, where appropriate.

• Leads/supports Client audits of the facility. Prepares for the audit/assessment activity by researching background information, including previous audit results. Assists in reviewing audit responses. Maintains the assessment file through the process to closure.
• Supports routine GMP and Pre-Approval Inspection regulatory audits. Prepares for audits by coordinating documentation, arranging facility tours, reserving conference rooms, and communicating with facility subject matter experts. Assists in pre- and post- audit communications with Global Quality and regulatory bodies. Interfaces with regulatory inspectors during audits.
• Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness.
• Conducting and confirming follow-up actions on Corporate, Client, Regulatory and Internal site compliance audits. Reports extended corrective actions to management.
• Performs procedure gap assessments to ensure compliance with Global Quality procedures.
• Maintains and makes recommendations for improvement to Quality procedures.
• Performs desktop evaluations of site’s suppliers per Global Quality procedures.
• Considered a Subject Matter Expert for department.
• Mentors other auditors.
• Trains subject matter experts for inspection readiness.

Qualifications:

• Bachelors degree required.  Preferably in a science or technical discipline.
• Minimum 5 years experience in the pharmaceutical industry, which should include at least 3 years of auditing experience.
• ASQ and/or RAB auditor accreditation is strongly desired.
• Extensive working knowledge of applicable quality and regulatory standards and regulations.
• Excellent communication skills – both written and oral.
• Work effectively independently and in team environment.
• Must demonstrate sound judgment and analytical skills to enable assessment of risk.
• Expertise in GMP regulations.
• Ability to demonstrate strong organizational skills.
• Good working knowledge of Windows based applications.
• Resourceful, self-reliant, self-motivated and confident.
• Working knowledge of quality software system (e.g. TrackWise, Veeva).
• General knowledge of Lean Six Sigma and other continuous improvement tools.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Quality Associate I is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Line Operations Lead. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
• In-process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
• Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
• Performs Quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight.
• Works in collaboration with management teams to prepare for internal and external audits. Assists with timely closure of audit observations and CAPAs.
• Initiates and authors Nonconformance Reports and corrective and preventative action responses.
• Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods.
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
• Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

The qualifications:

• Bachelor’s degree (preferred science discipline), or Associate’s degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, SAP, Maximo, TrackWise, etc.)

Physical / Safety Requirements:

• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade A/B areas.
• Duties will require overtime work, including scheduled weekend shifts
• Use of hands and fingers to manipulate office equipment is required
• Position requires standing for long hours, but may require sitting for periods of time

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra ist ein erstklassiges Auftragsentwicklungs- & Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.

Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.

Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. 

Für unser Team suchen wir Sie als Specialist (m/w/d) LIMS (befristet auf 12 Monate).

In dieser Position sind Sie in erster Linie für die Implementierung des LabWare LIMS (Laboratory Information Management System) zuständig. Im Einzelnen beinhaltet dieses:

• Mitgestaltung und Implementierung unseres neuen LabWare LIMS-Systems
• Entwicklung effizienter Workflows und Prozesse im LIMS
• Migration von Stammdaten aus unserem Legacy-System (LabVantage) in LabWare
• Enge Zusammenarbeit mit internationalen Teams und externen Consultants
• Konfiguration des Systems in Abstimmung mit internen Stakeholdern
• Erstellung von SOPs, Arbeitsanweisungen und Schulungsunterlagen
• Erstellung von Schulungsunterlagen
• Durchführung von Anwenderschulungen und Support

Sie bringen mit:

• Abgeschlossene Ausbildung mit entsprechender Berufserfahrung als Chemielaborant (m/w/d), CTA (m/w/d), Biologielaborant (m/w/d), Pharmakant (m/w/d) oder Fachinformatiker (m/w/d)
• Erfahrungen mit LIMS-Systemen wünschenswert
• Sehr gute Kenntnisse in Microsoft Word, Excel und Outlook
• Hohes Verantwortungsbewusstsein, Eigeninitiative und Organisationstalent
• Ausgeprägte Team- und Kommunikationsfähigkeit
• Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

Das bieten wir Ihnen:

• Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein 13. Tarifgehalt, Urlaubsgeld, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung
• Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung
• 30 Tage Urlaub plus Sonderurlaub
• Wochenarbeitszeit von 37,5 Stunden
• Job-Rad Leasing
• Corporate Benefits: Exklusive Rabatte für Mitarbeitende bei zahlreichen bekannten Marken
• Gute Verkehrsanbindung und kostenlose Mitarbeitendenparkplätze 
• Berufsbedingter Umzug? Wir unterstützen finanziell im Rahmen unserer Umzugskostenpauschale
• Kostenlose Betriebssportarten z.B. Badminton, Fußball und Fitnesskurse

Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.

Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.

Bei Rückfragen wenden Sie sich gerne an Selin Sencan (ssencan@simtra.com).

Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: » Recruiting Privacy Notice (DE)

Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- & Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.

Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.

Für unser Team Qualitätskontrolle suchen wir Sie als Chemielaborant (m/w/d) mit Schwerpunkt HPLC.

In dieser Position sind Sie verantwortlich für das GMP-gerechte Vorbereiten, Berechnen, Durchführen und Dokumentieren von Analysen nach eigenen als auch Kundenmethoden sowie den einschlägigen Pharmakopöen (Ph. Eur., USP und JP) auf dem Gebiet der HPLC. Im Einzelnen gehören zu Ihren Aufgaben:

• Termingerechte Bearbeitung von Prüfaufträgen gemäß Prüfvorschriften
• Dokumentation von Analysenergebnissen
• Durchführung von Methodentransfers und Validierungen
• Systematische Fehleranalyse bei Geräten und Methoden
• Erstellung von Standard-Arbeitsanweisungen und Prüfvorschriften

Sie bringen mit:

• Abgeschlossene Ausbildung zum Chemielaboranten (m/w/d). Berufsanfänger sind willkommen.
• Alternativ abgeschlossene Ausbildung zum chemisch-technischen Assistenten (m/w/d) mit einschlägigen Kenntnissen in der Flüssig-Chromatographie
• Gute Deutsch- und Englischsprachkenntnisse in Wort und Schrift
• Sorgfältige und gewissenhafte Arbeitsweise
• Bereitschaft zur Arbeit im 2-Schicht-Modell

Das bieten wir Ihnen: 

• Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein 13. Tarifgehalt, Urlaubsgeld, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung
• Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung
• 30 Tage Urlaub plus Sonderurlaub
• Wochenarbeitszeit von 37,5 Stunden
• Job-Rad Leasing
• Corporate Benefits: Exklusive Rabatte für Mitarbeitende bei zahlreichen bekannten Marken
• Gute Verkehrsanbindung und kostenlose Mitarbeitendenparkplätze
• Berufsbedingter Umzug? Wir unterstützen finanziell im Rahmen unserer Umzugskostenpauschale
• Kostenlose Betriebssportarten z.B. Badminton, Fußball und Fitnesskurse

Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.

Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.

Bei Rückfragen wende dich gerne an Selin Sencan (ssencan@simtra.com).

Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: » Recruiting Privacy Notice (DE)

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Microbiology Technician is an entry-level position in the Microbiology lab.  This position works independently to perform routine sampling and process samples in support of the Microbiology department. This position reports to a Microbiology Supervisor.

The responsibilities:

• Samples controlled environments per the sampling Master Plan utilizing aseptic technique.
• Documents and processes samples in a Laboratory environment.
• Performs real time risk assessments of the manufacturing areas and process.
• Accurately distinguishes and counts microbial recoveries (mold and bacteria)
• Enters data into Laboratory Information Management System.
• Maintains data integrity and ensures compliance with company standard operating procedures (SOP’s) and worldwide regulatory requirements
• Will be required to recognize non-conformances.

Desired qualifications:

• High school diploma or GED.
• Prior experience preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, LIMS etc.)
• Must be able to communicate well. 

Physical / Safety Requirements:       

• Must be able to gown qualify for Grade A/B area.
• The position sometimes requires extended periods of standing.
• Must be able to wear applicable Personal Protective Equipment.
• Duties may require overtime work, including nights, holidays, and weekends
• Use of hands and fingers to manipulate office and laboratory equipment is required
• Must be able to lift 20 lbs
• Must be able to qualify for 20/25 corrected vision and pass color blindness test.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra ist ein erstklassiges Auftragsentwicklungs- & Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.

Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.

Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen.

Das bieten wir Ihnen:

• Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein 13. Tarifgehalt, Urlaubsgeld, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung
• Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung
• 30 Tage Urlaub plus Sonderurlaub
• Wochenarbeitszeit von 37,5 Stunden
• Job-Rad Leasing
• Corporate Benefits: Exklusive Rabatte für Mitarbeitende bei zahlreichen bekannten Marken
• Gute Verkehrsanbindung und kostenlose Mitarbeitendenparkplätze 
• Berufsbedingter Umzug? Wir unterstützen finanziell im Rahmen unserer Umzugskostenpauschale
• Kostenlose Betriebssportarten z.B. Badminton, Fußball und Fitnesskurse

Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.

Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.

Bei Rückfragen wenden Sie sich gerne an Selin Sencan (ssencan@simtra.com).

Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: » Recruiting Privacy Notice (DE)

Simtra BioPharma Solutions (Simtra) ist ein erstklassiges Auftragsentwicklungs- & Herstellungsunternehmen, welches seit über 65 Jahren in Zusammenarbeit mit mehr als 60 internationalen Kunden weltweit sterile, injizierbare Arzneimittel auf den Markt bringt. Unser Hauptaugenmerk liegt hierbei auf der Herstellung von Krebstherapeutika. Mit der Unterstützung von über 2.000 Mitarbeitenden an unseren zwei Standorten in Bloomington, Indiana, USA und Halle/Westfalen, Deutschland, können wir unseren Kunden ein breites Portfolio von Verabreichungssystemen anbieten, darunter vorgefüllte Spritzen, flüssige/lyophilisierte Fläschchen, Verdünnungsmittel für die Rekonstitution, mit Pulver gefüllte Fläschchen und sterile Kristallisation. Neben der GMP-Herstellung bieten wir auch weitere Dienstleistungen an, darunter Unterstützung bei der Formulierung und Entwicklung, Gefriertrocknungsoptimierung, globale regulatorische Unterstützung sowie Sekundärverpackung.

Simtra wird aus vielseitigen Teams in verschiedenen Bereichen gebildet! Werden Sie ein Teil des Teams und unterstützen Sie zukünftig dabei Patienten weltweit lebensverändernde Medikamente zur Verfügung zu stellen.

Das bieten wir Ihnen:

• Faire tarifgebundene Vergütung inkl. Sozialleistungen wie ein 13. Tarifgehalt, Urlaubsgeld, betriebliche Altersvorsorge und eine zusätzliche Pflegeversicherung
• Hauseigene moderne Kantine mit attraktiver Be­zu­schus­sung
• 30 Tage Urlaub plus Sonderurlaub
• Wochenarbeitszeit von 37,5 Stunden
• Job-Rad Leasing
• Corporate Benefits: Exklusive Rabatte für Mitarbeitende bei zahlreichen bekannten Marken
• Gute Verkehrsanbindung und kostenlose Mitarbeitendenparkplätze 
• Berufsbedingter Umzug? Wir unterstützen finanziell im Rahmen unserer Umzugskostenpauschale
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Engagierten und begabten Menschen bieten wir interessante Chancen in allen Phasen des Berufslebens. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt.

Wir freuen uns über die Zusendung der Unterlagen zu Ihrem bisherigen beruflichen Werdegang direkt über unser Online-System.

Bei Rückfragen wenden Sie sich gerne an Selin Sencan (ssencan@simtra.com).

Um mehr über die Datenschutzrichtlinie von Simtra zu erfahren, lesen Sie bitte die globale Datenschutzrichtlinie der Simtra Recruitment Platform: » Recruiting Privacy Notice (DE)

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Sr Manager Quality, Contamination Control Strategy Lead is responsible for establishing, maintaining, and continuously improving the contamination control strategy at a sterile injectable manufacturing facility. He/she needs to drive compliance with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and contamination control initiatives, microbiological oversight collaboration, and aseptic assurance across the manufacturing site. This role serves as the SME (subject matter expert) for aseptic practices, maintenance of aseptic observation program data metrics, and the overall contamination control strategy (CCS).

The Sr Quality Manager is expected to contribute to an environment where teamwork and productivity are encouraged, and safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. In addition, the Sr Quality Manager is expected to partner with QALO and operations leadership, training leadership, and the Contamination Control Strategy Team.

The responsibilities:

• Owns the aseptic observer program, including oversight of aseptic practices, cleanroom behavior, and gowning:
1. Responsible for design and continuous improvement of the Aseptic Observer Program (aseptic manufacturing quality oversight)
2. Organize collected data from Aseptic Observer Program, analyze trends, lead cross functional review meetings, and make necessary improvements with operations leadership based on observations
• Leads the development and implementation of the Contamination Control Strategy (CCS) according to EU GMP Annex 1 and supports its governance in line with applicable regulatory requirements, organizing routine team meetings, annual updates of strategy document, and SME presentation of strategy for audits
• Assist with microbiological and sterility risk assessments for changes, deviations, and CAPAs involving aseptic operations.
• Serve as the SME during regulatory inspections and audits regarding aseptic processing, and contamination control.
• Present aseptic observation program data to site and executive leadership in management review forums, including trending and improvements made
• Collaborates with manufacturing, microbiology, and QC as the site steward of the Contamination Control Strategy (CCS), to ensure appropriate cleanroom qualification, media fill (process simulation), environmental monitoring, and glove/sleeve integrity programs.
• Supports contamination control assessments related to qualification and validation of equipment, utilities, (e.g. HVAC, WFI) isolators, RABS, and cleaning / disinfection procedures.
• Mentors and assists with training aseptic operators, and QA personnel in and contamination control. Responsible for Provide guidance on improvement and standardization of the QALO training program, including incorporation of industry and regulatory intelligence.
• Participate as needed in investigation and resolution of aseptic failures, sterility test failures, EM excursions, adverse trends and related aseptic non-conformances
• Review and approve GMP documents related to aseptic processing, (SOPs, protocols, reports, batch records).
• Lead continuous improvement projects related to aseptic behavior, risk mitigation, and cleanroom operations.

The qualifications:

• Education: Bachelors degree in Microbiology (preferred), Biology, Pharmacy, or related science.
• Masters degree or higher in Microbiology or Pharmaceutical Sciences is preferred
• Minimum of 8 years of direct experience in sterile pharmaceutical manufacturing or QC microbiology / QA roles, including at least 5 years in SME capacity related to contamination control.
• Demonstrated leadership or cross-functional team experience in aseptic processing environments (e.g. controlled areas (specifically A/B, isolators, OPEN and CLOSED RABS systems).
• Proven track record of successful regulatory inspection participation (FDA, EMA, or equivalent) as SME for contamination control topics
• Strong knowledge of EU GMP Annex 1, 21 CFR parts 210/211, USP<71>, <85>, <1116>, <797>, <1207> and current industry best practices
• Understanding of aseptic processing, data interpretation, aseptic filling processes and equipment strategies, CCS design, and Quality Risk management (ICH Q9).
• Strong communication skills as the role is expected to interface with clients, regulatory agencies, and site leadership, and being able to make decisions.
• Strong technical writing skills for strategy documents, assessments and investigations.
• Strong attention-to-detail, decision-making capability, and problem-solving in complex technical environments
• Ability to train, mentor, and coach staff in aseptic technique and contamination control.

Working conditions:

• Role requires frequent presence in Grade A/B aseptic environments; gowning certification is required.
• May require occasional off-shift, off-hours, support during media fills, regulatory inspections, or critical interventions

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The CAPA Manager is responsible for leading and managing the Corrective and Preventive Action (CAPA) Quality System to ensure compliance with corporate, client, and regulatory requirements. This role oversees investigations, root cause analysis, and implementation of effective corrective and preventive actions across the organization. The CAPA Manager collaborates with cross-functional teams and serves as a key point of contact for CAPA-related activities. This position reports to the Sr. Manager, Quality.

The responsibilities:

• Serve as the CAPA Program Owner, ensuring compliance with corporate and regulatory guidelines.
• Oversee day-to-day operation of the CAPA Quality System, including recurring CAPA meetings and timely closure of CAPAs.
• Lead and facilitate investigations for deviations.
• Utilize structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA) to identify root causes and implement effective corrective/preventive actions.
• Review and approve CAPA documentation for completeness and accuracy.
• Escalate quality issues to Sr. Manager, Quality or Quality Director as necessary.
• Train and qualify deviation authors, CAPA and Continuous Improvement (CI) owners and approvers to ensure competency in investigation and documentation processes.
• Trend overall CAPA metrics and perform root cause analysis on system performance to identify systemic issues and drive continuous improvement.
• Prepare and present CAPA metrics and trend reports for management review and regulatory inspections.
• Provide training and guidance to personnel on CAPA processes and best practices.
• Support internal, client, and regulatory audits related to CAPA activities.
• Partner with Manufacturing, Technical Services, Quality functions, and Engineering to ensure alignment and timely resolution of CAPA actions.
• Drive continuous improvement initiatives to strengthen the CAPA system and overall quality performance.

The qualifications:

• Bachelor’s degree required, preferably in a science-related field with a minimum 5 years of pharmaceutical or medical device industry experience, including management experience OR master’s degree with 3 years of pharmaceutical or medical device industry experience
• Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.
• Proven experience managing CAPA systems and leading investigations.
• Demonstrated ability to analyze and interpret quality data, trend metrics, and identify systemic issues using analytical tools.
• Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions, Power BI) is a plus.

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends.
• Position may require sitting or standing for long periods of time.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Quality Client Representative is a member of the core client team and interacts directly with clients. The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Quality Manager.

The responsibilities:

• Primary quality contact for assigned clients externally and internally.
• Manages client project quality updates and reviews with all levels of management.
• Responsible for making and delivering accurate and timely quality decisions pertaining to client projects,
• questions, and quality requests.
• Escalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for
• corrective action implementation.
• Partners with manager and Quality leadership staff to author, drive or approve applicable quality documents,
• as the Quality representative in a timely manner.
• Partners with Program Manager, Technical Services Representatives, Quality Control Representative and
• Manufacturing Representative to coordinate projects, provide support, align facility representation, and
• provide consistent quality information.
• Represents Quality in required Project Client Meetings.
• Understands the quality and technical requirements of each project.
• Maintains Project File, including recording and tracking quality interaction with client. Track, trend, compile,
• and report client quality metrics as necessary.
• Thoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master
• Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship
• and product.
• Assist and lead quality agreement contract negotiations
• Identifies and leads continuous improvement activities to maximize business results.

The requirements:

• Bachelor’s degree required, preferably in a science related field with 5 years pharmaceutical industry experience or a Master's degree with 3 years of pharmaceutical experience.
• Familiar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical,
• biological and biochemical quality.
• Knowledge of worldwide regulatory requirements
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software
• (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require sitting or standing for long hours of time

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

The Quality Systems Lead is responsible for managing electronic Quality Management System on a Global level. The Quality Systems Lead is a member of the Global team providing leadership, oversight and decision making to meet deliverables and ensure compliance to applicable policies, procedures, and regulations for projects of responsibility. The Quality Systems Lead must communicate effectively with internal team members, corporate team members, multiple levels of management, and external clients.

 The responsibilities:

• Provide project management leadership for Veeva QMS Workstreams (Quality Docs, Vault Training, QMS, Validation, etc)
• Responsible for creating reports, monitoring and maintaining system compliance, creating and owning governing procedures, managing new release activities, supporting validation and configuration activities
• Responsible for providing guidance and support for site requests and issue resolution. 
• Support site regulatory inspection requests.
• Serve as Business Administrator for Veeva eQMS
• Work with other Veeva System Leads and Veeva System Administrators to ensure continuity across workstreams
• Work with IT departments for integrations when data is shared cross-functionally
• Ensure compliance with all applicable policies, procedures, and regulatory requirements
• Ensure the appropriate level of harmonization between sites to efficiently meet customer and regulatory expectations.
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Regularly interact with senior management or executive levels on key quality projects
• Interface with the staff/customers to ensure Simtra quality commitments are met.
• Facilitate an environment of teamwork and communication between cross-functional departments and sites to meet Company goals/objectives.

Desired qualifications:

• Bachelor's degree in Life Sciences, Engineering, or related field
• 7 years experience in Quality / equivalent pharmaceutical industry experience
• Served in a role providing project management disciplines with proven experience for implementation and maintenance of electronic Quality Management software, PMP preferred.
• Experience with Veeva software, Quality Docs, Vault Training, QMS, Controlled Print
• Knowledge of GxP / CSV regulations
• Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams
• Excellent communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization
• Strong analytical and problem-solving skills, with the ability to identify and address complex issues in a timely manner
• Ability to thrive in a fast-paced and dynamic environment, with a commitment to continuous improvement
• Computer proficiency in Microsoft Word, Excel, Outlook, Visio, Project etc.

At Simtra, we recognize that attracting the best talent is key to our strategy and success as a company.  As a result, we aim for flexibility in structuring competitive compensation offers to ensure we are able to attract the best candidates.​

The pay range reflected represents what we reasonably expect to pay for this job. The pay offered will depend on factors such as the candidate’s education, experience, skills, and geographical location. In addition to base pay, employees are eligible to participate in an annual bonus plan and employee ownership plan. Eligible employees also receive a comprehensive and highly competitive benefits package, including a variety of health, retirement, caregiving, emotional wellbeing, and other flexible benefits—plus elective options to support the diverse needs of our workforce.​

Salary Range: $104,000-$143,000

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy