Quality Operations Lead – Compliance & Data Integrity

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

Benefits offered by this job

Relocation assistance

401(k) matching

Paid vacation and leave

Health benefits

Job summary

Pfizer is seeking a QO Manager Compliance/TL in Rochester, MI to lead a multidisciplinary Quality organization focused on compliance, QA documentation, supplier management, validation, sterility, and data integrity. The role interfaces with regulatory bodies and internal teams to ensure site readiness and continuous improvement.

The position requires strong leadership, cGMP experience, knowledge of quality systems, and ability to drive CAPA, risk management, and audits.

Qualifications

• Experience in a cGMP environment with broad quality systems knowledge.
• Ability to lead, coach and develop a multi-disciplinary team.
• Strong communication skills for internal and regulatory interactions.
• Knowledge of aseptic manufacturing and MDCP is a plus.

Responsibilities

• Provide leadership for Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, MDCP, and Data Integrity within Rochester Quality.
• Oversee audits/inspections and ensure site readiness and regulatory compliance.
• Develop and monitor quality metrics and oversee CAPA and QIP activities.

Skills

Quality systems

Leadership

Regulatory knowledge

Audits & inspections

Cross-functional collaboration

Education

BA/BS with experience

MBA/MS or 2 years experience

PhD/JD or 8+ years experience

High School Diploma with 10+ years

Associate degree with 8+ years

Tools

MS Office

Word

Excel

Access

Project

Trackwise

Job description

Pfizer is seeking a QO Manager Compliance/TL in Rochester, MI to lead a multidisciplinary Quality organization focused on compliance, QA documentation, supplier management, validation, sterility, and data integrity. The role interfaces with regulatory bodies and internal teams to ensure site readiness and continuous improvement.

The position requires strong leadership, cGMP experience, knowledge of quality systems, and ability to drive CAPA, risk management, and audits.