Quality Assurance Manager, Medical Device & Combination Products

Pfizer • St Louis, MO

1d • Hybrid

About The Position

The Quality Assurance Manager is a strategic contributor within Pfizer’s global Medical Device and Combination Products (MDCP) Quality Operations team. The role provides global quality oversight and partnership for the development, sustaining, and post-market activities of MDCP portfolios distributed across more than 50 markets. It supports Pfizer’s global quality blueprint and helps ensure delivery systems comply with international requirements, including ISO 13485, ISO 14971, EU MDR, 21 CFR Part 4, and FDA 21 CFR 820.

The manager provides strategic and technical quality guidance on design controls and risk management for complex programs, supporting risk-based decisions and compliance with applicable quality-system requirements. Working across functions, the role resolves quality and compliance issues, strengthens processes, and supports product quality, patient safety, and regulatory readiness. This is an independent-contributor role with no direct reports. Business travel to Pfizer manufacturing sites, vendors, and suppliers may be required. The position is hybrid, with on-premises work 2–3 days per week.

Requirements

• Bachelor’s degree and at least 4 years of relevant experience; or master’s degree and at least 2 years; or PhD and 0+ years; or associate’s degree and 8 years; or high school diploma (or equivalent) and 10 years.
• Relevant experience working in Quality Assurance, a GMP manufacturing environment, a pharmaceutical environment, or the medical-device field.
• Experience supporting quality activities in medical devices, combination products, pharmaceuticals, or another highly regulated industry.
• Working knowledge of applicable quality and regulatory requirements, including design controls, risk management, and quality-system requirements relevant to medical devices, combination products, or pharmaceuticals.
• 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.
• Must be authorized to work in the United States; U.S. work visa sponsorship is not available. Permanent U.S. work authorization is required.

Nice To Haves

• 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.

Responsibilities

• Lead global quality assurance oversight for multiple concurrent MDCP programs and next-generation delivery platforms, supporting global launches and continued market sustainability.
• Serve as a quality partner to global cross-functional teams, providing risk-based guidance on design controls, post-approval changes, supplier and component changes, manufacturing transfers, periodic product reviews, post-market surveillance, remediations, and obsolescence planning.
• Drive resolution of complex, multi-regional quality and compliance issues and recommend practical, compliant decisions.
• Monitor international regulatory changes, including EU MDR, TGA, ANVISA, NMPA, and FDA requirements, and translate them into 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 and support compliant decisions in a fast-paced, highly regulated environment.
• Identify and lead opportunities to strengthen processes, improve consistency, and advance quality-system maturity across MDCP development and sustaining activities.
• Promote consistent interpretation and application of quality policies and procedures across teams and activities.
• Apply technical expertise to later-phase product lifecycle activities, including verification, validation, process validation, stability considerations, and sustaining lifecycle management of marketed products.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer retirement savings contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligible to participate in Pfizer’s Global Performance Plan, with a bonus target of 12.5% of base salary.
• Eligible to participate in a share-based long-term incentive program.
• Relocation support may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED