Senior Manager Contractor Quality Lead
Core
Lead quality and compliance for a portfolio of external contract manufacturers, packagers, and suppliers globally to ensure product quality and regulatory adherence for Pfizer.
Role type
Senior Manager, Quality Operations (External Supply)
Builds
Quality assurance and compliance programs for external manufacturing partners
Domain
Pharmaceutical manufacturing and supply chain quality
Deliverable
client delivery
Required skills
GMP compliance, risk management, audit leadership, vendor quality assessment, continuous improvement, cross-functional project leadership, regulatory inspection support, batch disposition, quality agreement negotiation
Preferred skills
Pharmaceutical or medical device industry experience, technical writing, stakeholder management, conflict resolution, innovation in quality systems
Technologies
SAP, QTS, Vault, Documentum, Minitab
Responsibilities
Manage product quality and compliance for external contract manufacturers; assess supplier products and processes; lead internal and external auditing activities; support onboarding and offboarding of CMOs; manage risk and quality improvement plans; lead complex investigations and market complaints; develop and negotiate quality agreements; review Annual Product Review reports; implement continuous improvement initiatives.
Seniority
Senior Manager, hands-on leadership with strategic oversight
