Quality Operations Leader – Compliance & Validation

Pfizer; Michigan; Sur place; USD 106 000 - 177 000; Plein temps

Avantages offerts par ce poste

401(k) matching

Retirement savings contributions

Paid vacation/holidays

Parental leave

Health benefits

Résumé du poste

Pfizer is seeking aSenior Quality & Compliance Leader to guide the Rochester site’s Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity. You will coach a diverse team, approve activities, manage budgets, and ensure readiness for internal, corporate, and regulatory audits.

The role requires strong cGMP experience, people leadership, and superior communication.

Qualifications

• BA/BS with ≥4 years experience or MBA/MS with ≥2 years.
• Experience in a cGMP environment with quality systems knowledge.
• Strong people management and leadership abilities.
• Excellent written and verbal communication skills.
• Regulatory and audit readiness experience.

Responsabilités

• Lead site QA and Compliance programs and audits.
• Oversee QA Documentation, Supplier Management, Validation, Sterility.
• Monitor quality metrics and drive CAPA and continuous improvement.
• Coordinate cross-functional activities with regulatory agencies.

Connaissances

People management

Communication

Analytical thinking

Problem solving

Regulatory knowledge

Formation

BA/BS in related field

MBA/MS or equivalent

PhD/JD or alternative

Associate degree with 8+ yrs

HS diploma with 10+ yrs

Outils

MS Office

Word

Excel

Access

Project

Trackwise

Description du poste

Pfizer is seeking aSenior Quality & Compliance Leader to guide the Rochester site’s Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity. You will coach a diverse team, approve activities, manage budgets, and ensure readiness for internal, corporate, and regulatory audits.

The role requires strong cGMP experience, people leadership, and superior communication.