Sr Manager-QA Portfolio

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

The role is responsible for implementing and overseeing the processes and programs for Biotherapeutics (BTx) GMP R&D pipeline programs. This position has key responsibilities for the execution of the BTx Portfolio, leading to seamless lifecycle management and ultimate transfer to Pfizer Global Supply (PGS) sites or Contract Manufacturing Organizations (CMOs).

This position includes instilling and influencing a strong quality culture at multiple Pharm Sci and PGS BTx-facing sites globally. This position requires solid understanding of compliance regulations, process validation, Quality by Design concepts, and quality systems as they relate to manufacturing, testing, stability, scale-up, and development of cell culture/fermentation and purification processes to produce human biotherapeutics, vaccines, diagnostics, and combination products.

The successful candidate’s ability to meet project targets will help in completing critical deliverables. Innovative use of communication tools and techniques will facilitate explaining issues and create a collaborative team environment across various internal and external Quality groups, PharmSci and PGS.

How You Will Achieve it

Lead projects with complete accountability for Quality oversight of complex Biotherapeutic (BTx) projects inclusive of the following:

• Acquired assets/companies & associated Quality Integrations/Quality Integration Plans
• Partnerships/Collaborations with other Pharma Companies.
• Internal BTx pipeline programs. Many programs will be at an accelerated pace inclusive of programs which have a formally accelerated review with FDA or other boards of health due to an unmet medical need.

• Provide Quality & Compliance oversight to programs assigned to you.
• This position is responsible for providing quality oversight to BTx portfolio projects including disposition of Clinical Trial Material (CTM) including plasmids, cell banks, drug substance, drug product BTx products, including various modalities, vaccines/vaccine components, and device/combination products.
• Work with multiple CMOs, acquired, in licensed or out licensed companies, Pharm Sci (e.g., Andover, Chesterfield), and PGS BTx-facing sites (e.g., Puurs, Kalamazoo, McPherson, Andover, Grange Castle, Orth, Pearl River, Sanford, etc.) responsible for development, manufacturing, and testing investigational medicinal product supplies for use in human clinical trials. Establish and adhere to norms for collaboration and roles & responsibilities with other sites and quality groups.
• Act as PSOQ quality point of contact to PSPT and CDT project teams, BTx Pharm Sci sites, and various PGS sites for your programs.
• In collaboration with other groups, interpret, advise, and execute against evolving compliance regulations with respect to new focus areas or novel technologies/modalities such as multi-specifics, mABs, mRNA vaccines, nanoparticles, traditional vaccines, oncology and gene/cell-based therapies.
• Provide Quality oversight to external vendors/CMOs/acquired companies/partners responsible for manufacturing of drug substance or drug product including, but not limited to, release of materials for use in human clinical trials.
• In collaboration with business lines and Global Chemistry, Manufacturing and Controls (GCMC)/Global Regulatory Affairs(GRA) develop control and release strategies for your projects.
• Review/approve PSOQ global procedures that may impact quality systems and quality of CTM ensuring alignment with Pfizer PQSs and smooth interface with PGS sites as applicable. Work to develop procedures/processes that increase efficiency and maintain high-quality standards.
• In consultation with PSOQ BTx Portfolio lead, determines when a Notification to Management should be issued for a significant quality or compliance event.
• Author NTM.
• Provide training, guidance, and coaching to QA colleagues participating in various projects.
• Manage own time to meet agreed targets and develop plans for work activities within matrixed teams inclusive of Pharm Sci, PGS, or ex ternal CMO sites.

• Manage and author Quality Assurance Agreements in support of BTx programs inclusive of alliance partnerships & acquisitions and other pharma collaborations.
• Make GMP compliance and Quality decisions independently to resolve complex issues.