Senior Quality Assurance Compliance Specialist

Pfizer • Rochester, MI

23h • $82,700 - $137,900 • Onsite

About The Position

Pfizer is seeking a Senior Quality Assurance Compliance Specialist to support its commitment to delivering safe and effective products. The role contributes to patient care by maintaining a science- and risk-based quality culture and ensuring quality and safety. The specialist manages and supports quality-system activities for commercial drug products, including audits and inspections, customer complaints, supplier quality, investigations, data analysis, and continuous improvement. The position is on premise.

Candidates must be authorized to work in the United States for any employer. U.S. work visa sponsorship is not available. Permanent U.S. work authorization is required. Relocation assistance may be available based on business needs and eligibility. The annual base salary ranges from $82,700 to $137,900, with eligibility for Pfizer’s Global Performance Plan at a 10% bonus target. The listed U.S. salary range does not apply to Tampa, Florida, or locations outside the United States. Applications are due October 20, 2026.

Requirements

• High school diploma or equivalent and at least 8 years of experience; or associate’s degree and at least 6 years of experience; or BA/BS and at least 2 years of experience; or MBA/MS with relevant experience.
• Demonstrated skills conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes.
• Strong understanding of Quality System functions, manufacturing and packaging processes, validations, engineering drawings, and basic statistical processes.
• Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks.
• Excellent technical writing, communication, and presentation skills.
• Proficiency in Microsoft Office, Microsoft Project, and statistical software.
• Experience preparing for and participating in audits and inspections.
• Must be authorized to work in the United States for any employer; permanent U.S. work authorization is required. U.S. work visa sponsorship is unavailable.

Nice To Haves

• Background in handling complaints and using electronic lab systems.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Strong interpersonal skills and ability to communicate effectively with all levels of the organization.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously.
• Experience mentoring and training colleagues.
• Experience using common AI tools, including generative technologies such as Microsoft Copilot, to support problem solving and productivity; curiosity about their potential and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Evaluate CAPA responses to internal and external audit observations for adequacy, effectiveness, and timely completion.
• Keep Quality Assurance policies, procedures, and quality system records current and compliant with regulatory, corporate, and site requirements.
• Prepare for and support regulatory inspections, internal audits, supplier audits, and quality assessments; ensure resulting action plans are developed, implemented, and closed on time.
• Manage, investigate, and document customer quality complaints for commercial drug products in the global complaints management system, including root cause analysis, timely investigations, and appropriate quality decisions.
• Collaborate with internal stakeholders, manufacturing sites, suppliers, contract manufacturers, and quality partners to complete complaint investigations and quality records in accordance with procedures and regulatory expectations.
• Support supplier qualification, monitoring, performance trending, issue escalation, supplier corrective action management, and quality risk assessments as part of the Supplier Quality Management Program.
• Assist with technical investigations involving product-, process-, component-, and equipment-related quality issues, providing quality oversight and support for testing and protocol execution.
• Collect, analyze, interpret, and trend quality and operational data using statistical and risk-based methodologies to identify continuous improvement and risk mitigation opportunities.
• Review quality system documentation and performance metrics, conduct trend analysis, and identify emerging issues requiring corrective or preventive action.
• Promote and ensure compliance with current Good Manufacturing Practices, applicable regulatory requirements, data integrity principles, and company procedures.
• Support quality investigations, deviation management, change management, effectiveness verification, and continuous improvement initiatives across site quality systems.
• Prepare reports, presentations, and quality metrics to communicate findings, risks, recommendations, and quality system performance to management and stakeholders.

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.
• Eligible to participate in Pfizer’s Global Performance Plan with a bonus target of 10% of base salary.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

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