Quality Assurance Manager, Medical Device & Combination Products

Pfizer • St Louis, MO

5d • Hybrid

About The Position

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

The position partners with global, cross-functional teams and provides strategic and technical guidance on design controls, risk management, product lifecycle activities, and quality-system requirements. It supports quality and regulatory readiness, product quality, and patient safety by resolving complex issues, promoting consistent application of policies and procedures, and strengthening quality systems. The role is an independent contributor with no direct reports. The work arrangement is hybrid, with on-premise work 2–3 days per week, and may include business travel to Pfizer manufacturing sites, vendors, and suppliers.

Requirements

• Meet one of the following education and experience combinations: bachelor’s degree and at least 4 years of experience; master’s degree and at least 2 years; PhD and 0 or more years; associate’s degree and 8 years; or high school diploma/equivalent and 10 years of relevant experience.
• Relevant experience must be in Quality Assurance, a GMP manufacturing environment, a pharmaceutical environment, or the 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, 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.
• Must be authorized to work in the United States; U.S. work visa sponsorship is not available.

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 global MDCP programs and next-generation delivery platforms, supporting global launches and ongoing 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, product remediation, and obsolescence planning.
• Drive resolution of complex, multi-regional, business-critical quality and compliance issues and provide recommendations for practical, compliant decisions.
• Monitor changing international regulations and translate evolving requirements into global policies, procedures, and quality-system practices.
• Evaluate investigations for completeness, scientific rationale, issue linkage, risk alignment, and potential CAPA relevance.
• Partner with teams to resolve complex quality issues and enable sound, compliant decisions.
• Identify and drive 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-related 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, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 12.5% of base salary.
• Eligibility 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: Mid Level
• Education Level: High school or GED