Position Summary:

The Senior Manager, Quality Assurance (QA), will report to the Director, QA Drug Substance and is primarily responsible for QA function for Cell Bank and Drug Substance (DS). The position is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Substances meet regulatory requirements and internal Vera standards.

Responsibilities:

• Support the oversight of the quality and compliance, primarily cell bank and biologics DS manufacturing.
• Support implementation of strategies and tactics to promote and maintain GxP compliance.
• Provide quality support on tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of cell banks, commercial and clinical DS.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Provide quality support for validations including process validation, shipping validation, cleaning validation, etc.
• Provides support during both internal and regulatory agency audits as required.
• Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Participate in Quality Agreements negotiation with external partners.
• Support product lifecycle and continued process verification.
• Availability for 5-15% travel, both domestically and internationally.

Qualifications: 

• Bachelor’s degree with 10+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field or a Master’s degree with 7+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field.
• Minimum 6+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
• Minimum 6+ years in a GMP QA role, and preferably direct work experience in either Manufacturing or QC, as well.
• Excellent written and verbal communication skills, including demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Innovative skills with problem solving and peer influence.
• In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
• Experience of working with external partners and biologics DS manufacturing.
• Experience working with Cell Bank is a plus.
• Experience with process validation is a plus.
• Strong attention to detail is a must.
• Excellent interpersonal, written and oral communication skills.
• Outstanding organizational skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.

Position Summary:

The Senior Manager, Quality Assurance, Drug Product focus, will report to the Director, Quality Assurance. The Senior Manager is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Products and Devices meet regulatory requirements and internal Vera standards.

Responsibilities:

• Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements.
• Responsible for implementing strategies and tactics to promote and maintain GxP compliance.
• Lead quality aspects of and provide quality support on DP tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of commercial and clinical DP/ combination products.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc.
• Provides assistance during both internal and regulatory agency audits as required
  Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Lead for Quality Agreement with external partners.
• Support product lifecycle and continued process verification.
• Availability for 10-20% travel, both domestically and internationally.

Qualifications:

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred.
• Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
• Minimum 6+ years in a GMP QA role, with a preference for direct experience in biologics sterile DP manufacturing/aseptic processing including vials and prefilled syringes/autoinjectors.
• Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Innovative skills with problem solving and peer influence.
• In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
• Experience of working with external partners.
• Strong attention to detail is a must.
• Excellent interpersonal, written and oral communication skills.
• Outstanding organizational skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.
• Familiar with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is a plus.

Position Summary:

The Associate Director, Clinical Quality Assurance, will report to the Executive Director, Quality Assurance. The Associate Director, Clinical Quality Assurance serves as a key quality partner to clinical study teams and provides quality oversight of clinical development activities. This role contributes to strengthening a maturing Quality Management System (QMS) by identifying quality risks, supporting risk-based decision making, and ensuring quality practices are effectively implemented across clinical programs.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides quality oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness.

This role provides proactive Clinical Quality Assurance oversight for clinical studies and development functions. The individual partners closely with Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs, and other development function and  serves as a key member of study teams, helping identify quality issues and risks,  and reviews quality events, investigations, and CAPAs; analyzing quality signals across studies and vendors that support risk-based decision making, and ensuring quality management practices are appropriately implemented throughout the clinical trial lifecycle.

The role operates with a high degree of independence in evaluating quality risks and compliance considerations while collaborating closely with cross-functional teams to support effective implementation of quality practices across clinical development programs.

The position contributes to strengthening the organization’s maturing Quality Management System (QMS) by supporting procedural governance, audit program oversight, and quality process improvement initiatives.

Responsibilities:

• Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations.
• Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends.
• Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies.
• Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function.
• Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues.
• Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions.
• Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures.
• Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles.
• Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

Qualifications:

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required. Advanced degree preferred.
• Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance.
• Strong applied knowledge of global GxP regulations applicable to clinical development, including:
  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice (GVP)
  • Good Laboratory Practice (GLP)
  • GMP experience is not required for this role
• Experience with the following is desired:
  • Quality management and oversight of clinical trials
  • Quality event and CAPA management
  • Regulatory inspection readiness and inspection support
  • Risk-based quality management approaches
  • Planning of clinical audits (including sites, internal audits)
  • Developing metrics and reviewing issues for quality signals and trends
  • SOP governance through controlled document reviews
  • Training matrix or training governance activities
• Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.

Position Summary:

Reporting to the Executive Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for supporting Clinical Development programs by performing Statistical Programming tasks as well as building and computing the analytical programming environment.

Responsibilities:

• Oversee and work directly with CROs to provide guidance, effectively monitor and QC their deliveries for quality, time and budget adherence.
• Follow CDISC SDTM and ADaM standards and guidelines; validate SDTM, ADaM datasets and TFLs generated by the CRO.
• Work with the internal teams and CRO to prepare submission-readiness datasets (e.g. SDTMs, ADaMs) and metadata to support the BLA filing.
• Hands-on statistical programming to support CSR, publications, presentations, DSUR, IB update, safety data review, RTQ, and ad hoc analyses.
• Attend SMT and collaborate with the study statistician and other study team members in project planning and timeline discussions.
• Review key study documents including but not limited to study protocol, SAP, and CDM documents like CRF and DTA and provide inputs to represent statistical programming function.
• Work collaboratively with stakeholders and other developmental functions to standardize, maintain, and implement the data transformation and statistical analysis requirements.
• Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
• Familiar with SAS server working environment and adherent to server and programming SOP.
• Proficiency in R for statistical analysis, data analysis, modeling, and data visualization

Qualifications:

• BS (10+ years) or MS (8+ years) in Statistics, Life Sciences, Computer Science or related fields and statistical programming experience in the pharmaceutical industry.
• Experience with immunological diseases is preferred.
• Excellent project and vendor management skills, directly managing CROs/vendors is preferred.
• Experience with BLA or NDA/sNDA with FDA (EMA is a plus).
• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat; hands on experience with R and JMP is a plus.
• Extensive experience managing CROs for clinical and statistical programming activities
• Broad knowledge of medical/biological terminology in relevant therapeutic areas, good knowledge of drug development regulations for statistical analysis.
• Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
• Great communication skills, with the ability to effectively develop and deliver strategically, while aligning and gaining the collaboration of cross-functional groups.
• Able to effectively lead functional and cross-functional projects of varying scope and complexity while prioritizing resource needs
• Strong hands-on programming skills to deliver results in a quick turnaround environment.

The TMF Manager will report to the Executive Director, Clinical Quality Assurance and will support the quality and integrity of the Trial Master File (TMF) and electronic Trial Master File (eTMF) across clinical programs. This role helps ensure clinical trial documentation is complete, accurate, and maintained in accordance with regulatory requirements and industry standards throughout the clinical trial lifecycle.

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides independent oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness.

This role provides oversight of Trial Master File management to ensure clinical trial documentation is organized, complete, and maintained in a state of continuous inspection readiness for our Vera studies. The individual partners with study teams, functional document owners, and system users to monitor TMF health, identify documentation gaps, and support effective TMF management throughout the lifecycle of clinical studies.

The position also serves as the eTMF system administrator and collaborates with Clinical Quality Assurance leadership to support system governance, implement improvements through appropriate change control processes, and provide training and guidance to study teams and functional stakeholders.

The role operates with a high degree of independence in monitoring TMF quality and completeness while working closely with cross-functional teams to ensure documentation practices align with regulatory expectations and organizational procedures.

Responsibilities:

• Provide oversight of Trial Master File management across clinical development programs and functions. The position partners closely with Clinical Operations, Clinical Supply Chain, Data Management, Pharmacovigilance, Regulatory Affairs, and other development functions to ensure essential clinical documentation is appropriately maintained within the TMF. Partner with study teams, functional document owners, and system users to facilitate periodic TMF health discussions and ensure alignment on TMF quality and completeness expectations.
• Interface with CROs and external vendors responsible for TMF activities and contributes to maintaining TMF inspection readiness across the organization. In addition, the position supports TMF lifecycle activities including study start-up planning, ongoing TMF maintenance, study closeout, and TMF archival in accordance with regulatory and company retention requirements.
• Contribute to establishing and maintaining consistent TMF management practices across studies and programs to support alignment with regulatory expectations and industry best practices.
• Conduct routine TMF health reviews and collaborate with study teams and document content owners to identify documentation gaps and ensure appropriate remediation.
• Oversee quality, completeness, and timeliness of Trial Master File (TMF/eTMF) documentation across clinical studies, ensuring appropriate governance of TMF practices across study teams and functional document owners.
• Develop and track eTMF metrics for studies and communicate trends or issues identified to study teams and management
• Serve as the eTMF system administrator, supporting user access management, system configuration support, troubleshooting, and ongoing optimization of system functionality to support TMF quality and inspection readiness.
• Support regulatory inspections and internal audits involving TMF records and management, including providing eTMF navigation and demonstration of TMF document structure and audit trail traceability.
• Collaborate with the Head of Clinical Quality Assurance and system users to identify opportunities to improve TMF processes, system functionality, and inspection readiness practices.
• Work with the eTMF system owner and IT or system support teams to implement system improvements in accordance with required change control and validation procedures.

 Qualifications:

• Bachelor’s degree plus 8 Years experience in life sciences, pharmacy, or related scientific discipline or commensurate work experience managing TMFs.
• Pharmaceutical, biotechnology, or CRO experience with direct involvement in Trial Master File management desired.
• Strong knowledge of regulatory requirements and industry expectations related to clinical trial documentation and Trial Master File management.
• Trial Master File (TMF) oversight and electronic TMF systems.
• Clinical trial documentation requirements and the TMF Reference Model.
• TMF health review and document completeness monitoring.
• Regulatory inspection readiness and inspection support.
• Cross-functional collaboration with clinical development functions.
• Working knowledge of global Good Clinical Practice (GCP) requirements and regulatory expectations for clinical trial documentation.
• Experience contributing to:
  • TMF process improvement initiatives
  • eTMF system administration or system governance
  • TMF metrics development and monitoring
  • TMF closeout and archival processes
• Experience working with CROs or vendors responsible for TMF activities.