Quality Operations Leader, Compliance & Data Integrity

Pfizer; Rochester (MI); On-site; USD 106,000 - 177,000; Full time

Benefits offered by this job

Relocation assistance

Health benefits

Bonus target

Job summary

Pfizer, Rochester Quality, seeks a senior leader to oversee Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, MDCP quality, and Data Integrity. You will guide cross-functional teams, ensure regulatory readiness, and drive continuous improvement across the site.

The role requires strong leadership, deep QA knowledge, and hands-on experience with cGMP, audits, and CAPA. Attractive base salary with bonus eligibility and relocation support may apply; on-site role in

Qualifications

• BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience
• Experience in a cGMP environment, with a strong working knowledge of a variety of quality systems, aseptic manufacturing and processes including Drug and Combination products
• Excellent written and verbal communication skills across levels and regulatory agencies
• Strong people management experience and ability to lead cross-functional teams
• Knowledgeable in aseptic processes, environmental monitoring, validation, and CAPA processes

Responsibilities

• Provide leadership for Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity within the Rochester Quality organization
• Coach QO colleagues and oversee performance reviews and audits/inspections
• Manage site QIP and IR programs and communicate with key customers and partners
• Oversee department operations, assets, budget, and personnel; ensure inspection readiness
• Coordinate supplier management, MDCP activities, investigations, and annual product reviews

Skills

People management

Quality systems

Regulatory audits

Data integrity

SOPs/documentation

Education

BA/BS degree

MBA/MS

PhD/JD (optional)

Tools

MS Office suite

TrackWise

Microsoft Project

Job description

Pfizer, Rochester Quality, seeks a senior leader to oversee Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, MDCP quality, and Data Integrity. You will guide cross-functional teams, ensure regulatory readiness, and drive continuous improvement across the site.

The role requires strong leadership, deep QA knowledge, and hands-on experience with cGMP, audits, and CAPA. Attractive base salary with bonus eligibility and relocation support may apply; on-site role in