QO Manager Compliance/TL
Core
Lead a team of Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity professionals to ensure site standards align with global Pfizer Quality Standards and regulatory guidance.
Role type
Senior Team Lead, Quality Operations (Compliance & Validation)
Builds
Inspection readiness state, Quality Improvement Plans, and regulatory compliance for medical devices and combination products.
Domain
Pharmaceutical/Medical Device Manufacturing (cGMP, Sterility Assurance)
Required skills
Team leadership, audit management, supplier management, validation oversight, sterility assurance, data integrity governance, risk management, change control, CAPA management, regulatory compliance monitoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Provide guidance and coaching to team members; oversee departmental budget and assets; communicate with key customers and partners; participate in internal, corporate, and agency audits/inspections; monitor and report quality metrics; manage QIP and IR programs; ensure alignment of policies with global standards; oversee validation and sterility assurance programs; lead Data Integrity Quality System; facilitate risk assessment activities.
Seniority
Senior, hands-on IC with team leadership
