Director, Quality Assurance – Drug Product Quality Operations

Use Your Power for Purpose

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering high-quality, safe, and effective products to patients. Our adaptable, innovative, and customer-focused quality culture ensures that your contributions in development, maintenance, compliance, or analysis through research programs will directly benefit patients. Your leadership will help us continue to meet and exceed the requirements of Pfizer and regulatory authorities, ensuring the quality of our products and fostering a culture of continuous improvement and innovation.

What You Will Achieve

Reporting to the Site Quality Operations Lead, this position is responsible for leading the quality strategy for continuous manufacturing across a 24/7 operation.

The role leads a 100–130‑person quality organization, ensuring robust quality systems that enable aseptic manufacturing and uninterrupted supply through effective risk management.

This position is responsible for driving quality culture and compliance and across the drug product lifecycle from Batch Issuance, across the manufacturing/packaging operations, through lot disposition. 

The position will advise Site Leadership of significant events, overseeing the site’s quality event escalation meetings, providing strategic oversight to the site’s programs for quality on the floor, environmental controls and QA product realization requirements.

The role provides oversight and coaching to leaders responsible for risk-based decision making supporting continuous manufacturing operations and provide strategic management and leadership of the sites Quality Operations functions encompassing the following operational business units: Vial Manufacturing, Carpuject/ Syringe Manufacturing, Visual Inspection, Packaging,  Pharmaceutical support areas (Dispensing/Compounding, Component Preparation, and/or Equipment Preparation), Warehouse operations and Retain Sample Management.

Interactions include Operations, Process Engineering, Technical Services, Validation, Compliance, Regulatory Affairs, FDA and other Regulatory Authorities, Network functions, and Supplier relations.
 

In this role, you will:

• Lead and develop a large, diverse quality organization, coaching leaders to enable effective risk-based decision making, strong quality culture, and consistent execution across all manufacturing and support functions.
• Responsible for individuals making real time risk-based decision making on the operations floor.  Role provides coaching and strategic leadership to the quality triage and elevation process. Role manages quality on the floor teams inclusive of aseptic coaching and aseptic environmental monitoring.
• This role is responsible for management and direct oversight of the sites controlled environment monitoring, encompassing @250K samples annually.   
• This role is responsible for the sites Batch Issuance, Batch Release/Disposition, and Quality Hold program.
• This role will provide oversight and leadership to individuals that analyze, develop, and improve quality systems and associated business processes, to achieve compliance with local, corporate, and global regulatory requirements and to drive continuous improvement.
• Serve as site approval authority for critical GMP documents ensuring regulatory compliance, data integrity, and effective quality risk management.   
• Provide support for site audits and inspection, ensuring effective response development, commitment management, and sustained compliance.
• Manage Resources to meet organizational goals:  Manage diverse team of Colleagues (performance reviews, development discussions, build teams, foster colleague engagement, deliver results, manage through others, etc.) Understand site financial systems and maintain departmental budget.  Understand Site Safety objectives and maintain safe working environment
   

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience
• Prior experience working in an Aseptic cGMP environment, with a strong working knowledge of a variety of pharmaceutical quality systems and processes.
• 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.

Bonus Points If You Have (Preferred Requirements):

• Seven plus years’ experience in quality assurance within the pharmaceutical, regulatory and /or biotechnology industry.