Sr. Quality Assurance Manager

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 Pharm Sci Sm. Molecule (PSSM (PTx)) GMP R&D pipeline programs. This position has key responsibilities for the execution of the PTx 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 PTx-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 solid, semi-solid small molecule dosage forms, 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, Pharm Sci and PGS.

How You Will Achieve It

•    Lead projects with complete accountability for Quality oversight of complex PSSM(PTx) projects inclusive of the following:

○   Acquired assets/companies & associated Quality Integrations/Quality Integration Plans

○   Partnerships/Collaborations with other Pharma Companies

○   Internal PTx 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

This position is responsible for providing quality oversight to PTx portfolio projects including disposition of Clinical Trial Material (CTM) drug substance, API, drug product intermediate, drug product, drug product, peptides, PTx products, including various modalities and combination products.

•    Work with multiple CMOs, acquired, in licensed or out licensed companies, Pharm Sci, and PGS PTx-facing sites 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, PTx Pharm Sci sites, and various PGS sites to programs assigned.

•    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, SDD, peptides, nanoparticles, traditional oncology, I&I and I&M therapies.

•    Provide Quality oversight to external vendors/CMOs/acquired companies/partners responsible for manufacturing of drug substance, API, drug product intermediate 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 projects assigned.

•    Review/approve PSOQ global procedures that may impact quality systems and quality of CTM ensuring alignment with Pfizer GSOPs and GWIs 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 PTx 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 external CMO sites.

•    Manage and author Quality Assurance Agreements in support of PTx programs inclusive of alliance partnerships & acquisitions and other pharma collaborations.

•    Make GMP compliance and Quality decisions independently to resolve complex issues.

•    Review complex investigations and provide guidance to colleagues and project teams on investigat