Quality Assurance Manager, Medical Device & Combination Products

This role is a strategic pillar within Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations global team. Serving as a key global quality partner, you will champion and govern development, sustaining, and post-market activities for MDCP portfolios distributed across 50+ worldwide markets. The Manager of Medical Device Quality Assurance supports the global quality blueprint, ensuring that MDCP delivery systems are developed and sustained in strict compliance with a diverse array of international regulatory standards including ISO 13485, ISO 14971, EU MDR, 21 CFR Part 4, and FDA 21 CFR 820. You will provide strategic and technical quality oversight for design control and risk management for complex programs and guide teams using risk-based decision-making helping ensure compliance with applicable design control and quality system requirements. You will work across functions to resolve issues, strengthen processes, and support product quality, patient safety, and regulatory readiness.

• Lead global quality assurance oversight for multiple concurrent global MDCP programs and next-generation delivery platforms, enabling the successful global launch and market sustainability of high-priority assets.
• Serve as a MDCP quality partnerfor global cross-functional teams, providing authoritative, risk-based guidance on design controls, post-approval changes, supplier/component changes, manufacturing transfers, periodic product reviews, post-market surveillance, product remediations, and obsolescence planning.
• Drive the resolution of complex, multi-regional business-critical quality and compliance issues, providing sound recommendations that enable practical, compliant decisions across diverse international markets and fast-paced regulatory environments.
• Actively monitor shifting international regulations (e.g., EU MDR, TGA, ANVISA, NMPA, FDA) and translate evolving requirements into unified global policies, procedures, and quality system practices.
• Evaluate investigation content for completeness, scientific rationale, issue linkage, risk alignment, and potential CAPA relevance.
• Partner with teams to resolve complex quality issues, provide sound recommendations, and enable practical, compliant decisions in a fast-paced and highly regulated environment.
• Identify and drive opportunities to strengthen processes, improve consistency, and advance quality system maturity across the MDCP development and sustaining space.

• Promote alignment in the interpretation and application of quality policies and procedures across teams and activities.

• Apply technical expertise across later-phase product lifecycle activities, including verification, validation, process validation, stability-related considerations, and sustaining lifecycle management of marketed products.

HERE IS WHAT YOU NEED (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience, working in Quality Assurance, GMP manufacturing environment, pharmaceutical environment, or medical device space.

• Experience supporting quality activities in medical devices, combination products, pharmaceuticals, or another highly regulated industry.

• Working knowledge of applicable quality and regulatory requirements, such as design controls, risk management, and quality system requirements relevant to medical devices and/or combination products or pharmaceutical products.

• Experience supporting product development and/or sustaining lifecycle activities, including change control and ongoing product maintenance.

• Ability to work effectively across cross-functional teams and make sound, risk-based decisions in complex or ambiguous situations.

• Strong communication, influencing, and collaboration skills.

• Strong analytical skills and ability to work effectively with quality documentation, systems, and data.

BONUS POINTS IF YOU HAVE (Preferred Requirements)

• Experience in both medical device and pharmaceutical quality environments, especially combination products.

• Strong experience with design controls and risk management across the product lifecycle, from development through launch and post-market sustaining.

• Experience supporting on-market product changes, post-approval changes, supplier or component changes, and manufacturing transfers.

• Experience with post-market surveillance, complaint evaluation, periodic product review, and remediation activities.

• Working knowledge of combination product regulations, including 21 CFR Part 4, and broader medical device regulatory expectations.

• Experience partnering with suppliers, vendors, or external manufacturers in a regulated environment.

• Experience applying a risk-based approach to complex quality decisions in fast-paced, cross-functional settings.

• Familiarity with verification, validation, process validation, usability, software, or other technical development areas relevant to medical device programs.