Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Engineer SM-API to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel, office, until the end of December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

Within Supply Chain Quality (SCQ) Geel, as a Quality Engineer SM-API, you are a key partner for Operations and Quality. You provide quality advice, review GMP documentation, and oversee the handling of non-conformances and corrective/improvement actions so that the timely release of our commercial API product portfolio can be achieved in compliance with applicable regulations.

Main Job Tasks and Responsibilities:

• Review and approval of non-conformances and CAPAs in support of the QA commercial Operations team.
• Review and approve GMP documentation such as procedures, work instructions, protocols and reports.
• Provide quality support to the production plants.
• Ensure that quality records (e.g., Change Controls) are processed on time and in compliance by providing quality, compliance and technical expertise.
• Participate in QA check rounds.
• Support for smaller optimization projects and tasks within the QA Commercial Operations team.
• Establish and maintain strong working relationships with Business and Quality partners.
  

Education and Experience:

• Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer).
• Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance and experience as release responsible is an asset.
• Experience in non-conformance handling is a must.
• In-depth understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Strong analytical and solution-oriented mindset; able to work flexibly under time pressure.
• Ability to make risk-based decisions under time pressure.
• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Experience with Quality Systems.
• Fluent in English and Dutch (spoken and written).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Engineer SM-API, Quality Assurance, Supply Chain, GMP, CAPA, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-TEMPORARY

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

ClinChoice is searching for an Environmental Healthy and Safety (EHS) Specialist to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE), open to either a temporary employee on a 12 month fixed term contract, or a freelancer.  

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Direct contact for all Environmental, Health and Safety related topics within the facility, for running and future operations.
• Ensure proper follow-up of incidents / good saves within the Business Unit including quality of reporting and investigations, including leading or facilitating incident investigations and reporting outcome to management.
• Coach, lead Environmental, Health and Safety Representatives/Ambassadors on the shopfloor.
• Understand Business Unit Environmental, Health and Safety competency gaps and work with Environmental, Health and Safety Standard Owners on closing these gaps.
• Perform Environmental, Health and Safety assessments within Business Unit projects and changes.
• Participate in internal/external audits and inspections (for example ISO 14001/45001, J&J EHS Comprehensive Audits, governmental agencies) and coordinate the Business Unit preparation for these audits.
• Support and conduct Environmental, Health and Safety related risk assessments like facility, ergonomic, chemical and biosafety risk assessments and mitigation plans.
• Collaborate with the Environmental, Health and Safety department, Biosafety Officer and the Operational Standard Owner.
• Present periodically to the Operation Readiness Team and relevant stakeholders.
• Working pro-actively.
• Monitor the Business Unit Environmental, Health and Safety processes and performance by trend analysis of data and define follow-up.
• Develop multi-year Environmental, Health and Safety strategy and plan for the business unit.

Education, Experience and Skills:

• 2-4 years (operations) experience in a biotechnology or biopharmaceutical industry environment.
• Bachelor’s degree in safety (e.g., HVK, industrial hygiene or equivalent education).
• Proactively sees and finds work, knowing and visibly taking ownership of responsibilities.
• Excellent communication skills, written and verbal in English (required) and Dutch (preferred).
• Stimulating open communication when mistakes are made/problems arise.
• Dares to say no, can deal with uncertainties, escalates clearly and timely, can adapt communication style to the situation, can absorb complex information and views self-improvement as a priority and acts as a role model.
• Recognizes, acknowledges, and involves employees with different backgrounds, talents, knowledge, and ideas.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Environmental Health & Safety, EHS, CRO, Contract Research Organisation, Outsourced, Pharmaceutical, Pharma

#LI-LG1 #LI-HYBRID

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Data Integrity Specialist, Quality Assurance Computer Systems Validation (CSV) to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially.

The Data Integrity Specialist will focus on Innovative Medicine Supply Chain systems, primarily from our client in Beerse. Hybrid working with 2 days working from home per week is permitted.   

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Cooperate with multifunctional teams to assess local systems and equipment.
• Define risks and vulnerabilities for the local systems and equipment.
• Provide Data Integrity guidance and support towards local Subject Matter Experts.
• Define remediation activities and create Data Integrity plans.
• Act as local Process Owner for Data Integrity.
• Support the Small Molecules Data Integrity Community of Practice.
• Organize and lead sessions with Data Integrity representatives of multiple sites.
• Assist site Subject Matter Experts with the assessment process of all site specific systems and equipment.
• Assist Site Subject Matter Experts with Data Flow Mapping and Risk Assessments.
• Organize, manage and perform SM Platform based Data Flow Mapping and Risk Assessments.
• Maintain a current knowledge of international laws, guidelines and new evolutions related to Computer System Validation through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Computer System Validation at sponsor.
• Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.
• Be an Subject Matter Expert for Data Integrity matters during audits and inspections.
• Cooperate with engineering, IT and other teams for the Data Integrity compliance during introduction of new systems, equipment and processes.
• Give advice and support for the preparation of Computer System Validation related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.

Education, Experience and Skills:

·        Master scientific degree or equivalent experience.

·        3 years’ experience in the pharmaceutical industry.

·        Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, EU Directive 2003/94/EC, EU Directive 2017/1572 and annex 11; GAMP, Data Integrity Guidelines).

·        Strong ownership and Quality mindset. You are able to deliver on commitment timelines.

·        Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.

·        Experience with Data Integrity remediation activities.

·        Experience with Computerized System Validation.

·        Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Data Integrity Specialist, Computer Systems Validation, DIS, CSV, Quality Assurance, Temporary

#LI-LG1 #LI-Hybrid

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a CAR-T Quality Assurance Engineer to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially.

The Engineer will be responsible for the review and approval of qualification and requalification activities, related to Facilities and Utilities and Process Equipment at our client’s facility in Ghent.  

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Work closely with the Make Asset Management and Engineering & Property Services department to guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities and utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventative actions are defined and implemented.
• Work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented.
• Build strong connections with different quality organizations.
• Manage the compliance status of critical production assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews.
• Participate in the preparation for regulatory and customer inspections and act as a spokesperson for Quality Assurance qualification.
• Approve qualification documents (change controls, master documents, protocols, reports, rationales, SOP’s, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities.
• Participate in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert.

Education, Experience and Skills:

·        Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences

·        Awareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend our strategy and documents towards health authority inspections.

·        Affinity with computerized systems, System parameter configurations and data management in critical production assets.

·        Ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment.

·        Thorough knowledge of Dutch and English, both orally and in writing

·        Strong analytical thinking, risk assessment, and communication skills

·        Collaboration and teaming skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Engineer, CAR-T, QA Officer, Quality Officer, Quality Assurance Specialist, QA Specialist, Temporary#

#LI-LG1 

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Analyst, Qualification Facility & Utility to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel office, until 31 December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

In this role you will support the QA Engineering department in assuring that all Qualification related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Geel Facility and Utility systems.

Main Job Tasks and Responsibilities:

• Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analysis’s, Test Plans, test scripts, change controls, CAPA’s etc. in order to maintain compliance to regulations, guidelines, and Company policies and standards.
• Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification related activities and guard the cGMP aspects.
• Address and follow-up of deviations occurred during execution of qualification activities.
• Communicate status (quality & compliance, planning) towards Company QA Qualification team members.

Education and Experience:

• University/Bachelor’s Degree or Equivalent.
• Experience in chemical and/or pharmaceutical industry with respect to qualification of equipment.
• Knowledge of cGMP regulations and guidelines.
• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
• Ability to multi-task and work on a variety of projects at one time.
• Ability to work independently and work in cross-functional team environment.
• Good communication skills.
• Fluent in English and Dutch (spoken and written).
• Facility and Utility systems used within pharmaceutical or chemical industry.
• Problem report, change request systems. (f.e. Trackwise, Comet).
• Document Management systems (f.e. TruVault).
• Test tools (f.e. Kneat).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Analyst, Qualification Facility & Utility, Quality Management System, CAPA, GMP, Regulatory Compliance, Technical Documentation, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-ONSITE #TEMPORARY

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Qualification Contractor to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel office, until 31 December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

In this role you will support the QA Engineering department in assuring that all Qualification related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Geel manufacturing systems.

Main Job Tasks and Responsibilities:

• Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analysis’s, Test Plans, test scripts, change controls, CAPA’s etc. in order to maintain compliance to regulations, guidelines, and Company policies and standards.
• Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification related activities and guard the cGMP aspects.
• Address and follow-up of deviations occurred during execution of qualification activities.
• Communicate status (quality & compliance, planning) towards Company QA Qualification team members.

Education and Experience:

• University/Bachelor’s Degree or Equivalent.
• Experience in chemical and/or pharmaceutical industry with respect to qualification of equipment.
• Knowledge of cGMP regulations and guidelines.
• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
• Ability to multi-task and work on a variety of projects at one time.
• Ability to work independently and work in cross-functional team environment.
• Good communication skills.
• Fluent in English and Dutch (spoken and written).
• Manufacturing systems used within pharmaceutical or chemical industry.
• Problem report, change request systems. (f.e. Trackwise, Comet).
• Document Management systems (f.e. TruVault).
• Test tools (f.e. Kneat).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Qualification Contractor, Quality Management System, CAPA, GMP, Regulatory Compliance, Technical Documentation, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-ONSITE #TEMPORARY

Are you a Quality Assurance expert looking for the best of both worlds?

Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a leading CRO? Our team calls it the best of both worlds, and we think you’ll agree.

ClinChoice, a fast-growing global contract research organization, is expanding its Quality Assurance team in the Netherlands. We’re seeking experienced Quality Assurance Specialists focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. Experience within quality and compliance for new products being developed and produced for clinical trials and early launch. Provide QA support for commercial and clinical production at the manufacturing site, serve as the main point of contact for all quality-related matters. Ensure GMP compliance, review manufacturing activities, and collaborate closely with internal teams and external partners across various departments and companies.

Are you interested in partnering with some of the world’s leading pharmaceutical companies in the field of biomedicine? If that sounds like you, we encourage you to submit your resume via our website. We're growing our network and would love to connect with you!

Main responsibilities include:

• Provide quality oversight for the AT production facility and ensure GMP compliance.
• Support GMP processes including change control, documentation, training, and inspection readiness.
• Offer QA guidance on facility/equipment design, tech transfers, validations, aseptic processing, and Annex 1.
• Review investigations, assess non-conformances, and approve CAPAs and product dispositions.
• Support and participate in risk assessments and lead GMP training initiatives.
• Promote a strong quality culture through activities such as GEMBA walks.
• Review and approve document changes and contribute to local/global quality projects.
• Optimize quality monitoring processes and tools.
• Act as QA representative during regulatory inspections and on-call support rotation.
• Partner with site teams to manage changes and mitigate compliance risks.
• Serve as a QA SME for audits, studies, and JBV (quality-related) projects.

Education and Experience:

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
• Depending on education, BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC).
• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
• Proven knowledge of the biotechnological/pharmaceutical industry.
• Proficiency in English both in word and in writing.
• Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines in Operations environment.
• Functions independently in a complex environment to make daily judgments to balance business need, regulatory requirements, and cost efficiency for all Quality decisions. It is required to determine the level of risk, magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management.
• Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities and technical automation.
• Problem solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues.
• Ability to drive collaboration in a fast-paced environment.
• Has good negotiation skills with a customer-oriented attitude. Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints.
• Empowered professional who can make well motivated pragmatic decisions on their own.

The Application Process

• Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

• ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

• Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates.
• ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate i

Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self-employed, Contract, Site Management, Monitor, Monitoring, Complex Trials, Medical Devices, Cardiology, Neurology, Open to Travel, Submissions, Ethics, Contract Research Organisation, CRO

 #LI-VH1 #LI-CONTRACT #LI-1FTE