Sr Manager-QA Portfolio
Pfizer
4 hours ago
Remote friendly (Andover, MA)
United States
Operations
What You Will Achieve
- Implement and oversee Biotherapeutics (BTx) GMP R&D pipeline processes and programs.
- Execute the BTx Portfolio, leading seamless lifecycle management and transfer to Pfizer Global Supply (PGS) sites or CMOs.
- Instill and influence a quality culture at multiple Pharm Sci and PGS BTx-facing sites globally.
How You Will Achieve It (Responsibilities)
- Lead projects with end-to-end accountability for Quality oversight of complex BTx projects, including acquired assets/companies, partnerships/collaborations, and internal pipeline programs (including accelerated FDA/board reviews).
- Provide Quality and Compliance oversight, including disposition of Clinical Trial Material (CTM) (plasmids, cell banks, drug substance, drug product across modalities: vaccines/vaccine components, and device/combination products).
- Work with CMOs/acquired/licensed companies, Pharm Sci sites, and PGS sites for development, manufacturing, and testing of investigational medicinal product supplies.
- Serve as PSOQ quality point of contact for PSPT and CDT project teams and relevant sites.
- Interpret and execute against evolving compliance regulations for novel technologies/modalities (e.g., multi-specifics, mAbs, mRNA vaccines, nanoparticles, oncology, gene/cell therapies).
- Provide Quality oversight to external vendors/CMOs for release of materials for human clinical trials.
- Develop control and release strategies with business lines and GCMC/GRA.
- Review/approve PSOQ global procedures impacting quality systems and CTM; author Notifications to Management (NTM) for significant quality/compliance events.
- Train, guide, and coach QA colleagues; manage work plans across matrixed teams.
- Author/manage Quality Assurance Agreements for BTx programs, including alliances/acquisitions.
- Make independent GMP compliance/Quality decisions; review investigations and support recalls and quality review teams.
- Support inspection readiness; participate in audits/inspections (including pre-approval).
- Escalate issues beyond scope to PSOQ LT leader; lead/participate in improvement initiatives (RFT, CAPA effectiveness).
Here Is What You Need (Minimum Requirements)
- BS in relevant scientific discipline + 6+ years; OR MS + 5+ years; OR PhD + 1+ years.
- Relevant pharmaceutical industry experience.
- Sound knowledge of BTx manufacturing/testing for modalities (vaccines, gene therapies, antibodies, drug conjugates, therapeutic proteins).
- 4+ years’ experience in BTx Portfolio project overseeing PSPT and Co-Dev teams for Quality/Compliance.
- Sound knowledge of current GMP and applicable GxP regulations/standards.
- Sound knowledge of GMP documentation review (investigations/CAPA/change management, test methods, master/executed batch records, stability data).
- Experience with GMP electronic systems/tools.
- Mediation/negotiation skills.
- Ability to work independently and in matrixed teams; excellent communication and critical thinking; effective written/oral communication; self-motivated.
Bonus Points If You Have (Preferred Requirements)
- Operational risk/compliance management and hands-on Quality Operations (QO) experience.
- Strong technical understanding of project modalities; strong analytical/problem-solving skills.
- Ability to influence/lead cross-functional teams.
- Experience with AI tools (e.g., ChatGPT, Microsoft Copilot) and responsible AI practices.
- Demonstrated leadership (influence/collaboration, coaching, oversight of colleagues).
Physical/Mental Requirements
- Mental agility to handle a broad scope of Quality Assurance Agreement partnerships; ability to independently problem-solve and recommend solutions.
Work Schedule/Location
- Flex: Monday–Friday, typically 8:00am–4:30pm; hybrid work.
- Some travel (~4x/year).
Application Instructions
- Last date to apply: April 20, 2026.
- Implement and oversee Biotherapeutics (BTx) GMP R&D pipeline processes and programs.
- Execute the BTx Portfolio, leading seamless lifecycle management and transfer to Pfizer Global Supply (PGS) sites or CMOs.
- Instill and influence a quality culture at multiple Pharm Sci and PGS BTx-facing sites globally.
How You Will Achieve It (Responsibilities)
- Lead projects with end-to-end accountability for Quality oversight of complex BTx projects, including acquired assets/companies, partnerships/collaborations, and internal pipeline programs (including accelerated FDA/board reviews).
- Provide Quality and Compliance oversight, including disposition of Clinical Trial Material (CTM) (plasmids, cell banks, drug substance, drug product across modalities: vaccines/vaccine components, and device/combination products).
- Work with CMOs/acquired/licensed companies, Pharm Sci sites, and PGS sites for development, manufacturing, and testing of investigational medicinal product supplies.
- Serve as PSOQ quality point of contact for PSPT and CDT project teams and relevant sites.
- Interpret and execute against evolving compliance regulations for novel technologies/modalities (e.g., multi-specifics, mAbs, mRNA vaccines, nanoparticles, oncology, gene/cell therapies).
- Provide Quality oversight to external vendors/CMOs for release of materials for human clinical trials.
- Develop control and release strategies with business lines and GCMC/GRA.
- Review/approve PSOQ global procedures impacting quality systems and CTM; author Notifications to Management (NTM) for significant quality/compliance events.
- Train, guide, and coach QA colleagues; manage work plans across matrixed teams.
- Author/manage Quality Assurance Agreements for BTx programs, including alliances/acquisitions.
- Make independent GMP compliance/Quality decisions; review investigations and support recalls and quality review teams.
- Support inspection readiness; participate in audits/inspections (including pre-approval).
- Escalate issues beyond scope to PSOQ LT leader; lead/participate in improvement initiatives (RFT, CAPA effectiveness).
Here Is What You Need (Minimum Requirements)
- BS in relevant scientific discipline + 6+ years; OR MS + 5+ years; OR PhD + 1+ years.
- Relevant pharmaceutical industry experience.
- Sound knowledge of BTx manufacturing/testing for modalities (vaccines, gene therapies, antibodies, drug conjugates, therapeutic proteins).
- 4+ years’ experience in BTx Portfolio project overseeing PSPT and Co-Dev teams for Quality/Compliance.
- Sound knowledge of current GMP and applicable GxP regulations/standards.
- Sound knowledge of GMP documentation review (investigations/CAPA/change management, test methods, master/executed batch records, stability data).
- Experience with GMP electronic systems/tools.
- Mediation/negotiation skills.
- Ability to work independently and in matrixed teams; excellent communication and critical thinking; effective written/oral communication; self-motivated.
Bonus Points If You Have (Preferred Requirements)
- Operational risk/compliance management and hands-on Quality Operations (QO) experience.
- Strong technical understanding of project modalities; strong analytical/problem-solving skills.
- Ability to influence/lead cross-functional teams.
- Experience with AI tools (e.g., ChatGPT, Microsoft Copilot) and responsible AI practices.
- Demonstrated leadership (influence/collaboration, coaching, oversight of colleagues).
Physical/Mental Requirements
- Mental agility to handle a broad scope of Quality Assurance Agreement partnerships; ability to independently problem-solve and recommend solutions.
Work Schedule/Location
- Flex: Monday–Friday, typically 8:00am–4:30pm; hybrid work.
- Some travel (~4x/year).
Application Instructions
- Last date to apply: April 20, 2026.