Sr. Manager Quality Assurance

Pfizer • St Louis, MO

6d • Hybrid

About The Position

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 in explaining issues and create a collaborative team environment across various internal and external Quality groups, Pharm Sci and PGS.

Requirements

• Bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience.
• Degree in relevant scientific discipline.
• 7+ years relevant experience in the pharmaceutical industry.
• Sound knowledge of BTx manufacturing and testing technology for various modalities inclusive of vaccines, gene therapies, antibodies, drug conjugates and therapeutic proteins.
• 4+ years' experience in BTx Portfolio project overseeing PSPT and Co-Dev teams for Quality and Compliance.
• Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
• Sound knowledge of GMP documentation review inclusive of investigations/CAPA/change management, test methods, master and executed batch records, stability data, etc.
• Experience with GMP electronic systems and tools.
• Experience and talent in mediation and negotiation skills.
• Ability to work independently as well as in a team environment within own team and interdepartmental/matrixed teams.
• Excellent communication and interpersonal skills.
• Proactive approach and strong critical thinking skills.
• Effective written and oral communication skills.
• Self-motivated, engaged, and able to perform moderately complex tasks independently.
• Permanent work authorization in the United States.

Nice To Haves

• Master’s degree in relevant scientific discipline.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Responsibilities

• Lead projects with complete accountability for Quality oversight of complex Biotherapeutic (BTx) projects inclusive of acquired assets/companies & associated Quality Integrations/Quality Integration Plans, Partnerships/Collaborations with other Pharma Companies, and Internal BTx pipeline programs.
• Provide Quality & Compliance oversight to programs assigned.
• Provide 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, and PGS BTx-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, BTx Pharm Sci sites, and various PGS sites for your programs.
• 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.
• Develop control and release strategies for your projects in collaboration with business lines and Global Chemistry, Manufacturing and Controls (GCMC)/Global Regulatory Affairs(GRA).
• 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.
• Determine when a Notification to Management should be issued for a significant quality or compliance event and 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 BTx 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 investigations including Notifications to Management and Significant Quality Events (SQE).
• Support PSOQ BTx Portfolio Lead with Quality Review Teams (i.e., Area Quality Review Team (AQRT), PharmSci Quality Review Team (PSQRT)) and product recalls.
• Provide direction and support to PSOQ /BTx Pharm Sci sites relative to a constant state of inspection readiness.
• Participate in audits/inspections (inclusive of Pre-Approval Inspections) as needed.
• Recognize when an issue is beyond your sphere of influence and escalate to PSOQ LT leader.
• Participate in or lead Limited Duration Teams, Right First Time (RFT), and Continuous Improvement projects, Corrective/Preventative Action Effectiveness, etc. which may be PSOQ-centric or cross-functional where impact may often be global in nature.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures across both Pharm Sci and PGS.
• Lead and support initiatives that contribute to strengthening quality culture from a global and site perspective across Pharm Sci and PGS sites.
• Practice and encourage quality culture behaviors within quality and the business lines.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager