Senior QA Manager - Medical Devices & Combination Products

Pfizer; Cambridge; Hybrid; GBP 70,000 - 95,000; Full time

Job summary

Pfizer in Cambridge is seeking a Manager, Medical Device Quality Assurance to provide quality oversight across development and sustaining activities for MDCP programs. You will partner with cross-functional teams, guide risk-based decisions, and ensure design controls and quality system compliance across the product lifecycle.

The role emphasizes investigations, CAPA, regulatory readiness, and collaboration to sustain quality, safety, and patient outcomes.

Qualifications

• Bachelor’s degree with at least 4 years of experience; or a Master’s with 2+ years; or a PhD with 0+ years; or an Associate’s with 8 years; or a high school diploma and 10 years in QA, GMP, pharma, or medical devices.
• Experience in quality activities for medical devices, combination products, pharmaceuticals, or other regulated industries.
• Working knowledge of design controls, risk management, and quality systems for medical devices/pharma.
• Experience supporting product development or sustaining lifecycle activities, including change control and maintenance.
• Ability to work across cross-functional teams and make risk-based decisions.
• Strong communication, influencing, and collaboration skills.
• Strong analytical skills and ability to work with quality documentation and data.

Responsibilities

• Provide quality oversight for MDCP programs across development and sustaining lifecycle activities.
• Act as a quality partner for cross-functional teams, guiding design controls, risk management, quality systems, vendor management, change control, and complaint activities.
• Support on-market and sustaining activities, including post-approval changes and manufacturing transfers.
• Assess quality, safety, and regulatory impact of product and process changes to ensure design and risk documentation remains compliant.
• Review and approve device complaint investigations with rigorous documentation and timely closure.
• Evaluate investigation content for completeness, scientific rationale, risk alignment, and CAPA relevance.
• Collaborate with teams to resolve complex quality issues and enable compliant decisions in a fast-paced environment.
• Monitor global regulatory changes and translate requirements into policies, procedures, and quality practices.
• Identify opportunities to strengthen processes and advance MDCP quality system maturity.
• Promote alignment in interpreting quality policies across teams and activities.
• Apply expertise to verification, validation, process validation, and sustaining lifecycle considerations.

Skills

Quality Assurance

GMP Manufacturing

Regulatory Compliance

Design Controls

Risk Management

Change Control

Cross-functional teams

CAPA

Analytical skills

Communication

Education

Bachelor's degree

Master's degree

PhD

Associate’s degree

High school diploma

Job description

Pfizer in Cambridge is seeking a Manager, Medical Device Quality Assurance to provide quality oversight across development and sustaining activities for MDCP programs. You will partner with cross-functional teams, guide risk-based decisions, and ensure design controls and quality system compliance across the product lifecycle.

The role emphasizes investigations, CAPA, regulatory readiness, and collaboration to sustain quality, safety, and patient outcomes.