Manager, Quality Assurance
Core
Managing quality aspects at external suppliers for pharmaceutical products to ensure compliance with cGMP, regulatory requirements, and internal quality manuals.
Role type
Manager, External Supplier Quality Assurance
Builds
Pharmaceutical products and processes
Domain
Pharmaceutical industry / Quality Assurance
Deliverable
client delivery
Required skills
cGMP compliance, External supplier qualification, Technology transfer oversight, Quality auditing, CAPA management, Deviation/recall investigation, Change control management, Risk assessment, Continuous improvement
Preferred skills
FDA/EMA regulatory experience, Risk management tools, Pharmaceutical process knowledge
Technologies
None stated
Responsibilities
Lead external supplier qualification and act as SPOC for quality activities; Provide quality leadership for technology transfer activities; Review and approve transfer protocols and risk assessments; Coordinate and manage annual quality audits and CAPA follow-up; Manage critical quality issues including deviations, complaints, and recalls; Oversee change requests and drive continuous improvement; Collaborate with Supplier Relationship Manager on business strategy and reviews.
Seniority
Manager, operational leadership
