QA Product Manager
Core
Ensuring customer products meet quality and compliance standards throughout the full lifecycle in a regulated environment.
Role type
QA Product Manager
Builds
Customer-facing quality documentation, Quality Technical Agreements, and quality metrics/tracker reports.
Domain
Pharmaceutical / Medical Device / cGMP
Deliverable
client delivery
Required skills
FDA regulations knowledge, cGMP requirements expertise, quality documentation management, cross-functional coordination, audit and inspection support, quality metrics analysis, problem-solving in regulated environments
Preferred skills
Experience in QA roles within pharmaceutical or medical device environments
Technologies
Deviations, Investigations, Change Controls, CAPAs, Master Batch Records, Validation documents, APRs, Product Specifications
Responsibilities
Lead and approve customer-facing quality documentation; Coordinate cross-functional teams for quality activities; Develop and maintain Quality Technical Agreements; Generate and analyze quality metrics and reports; Support customer audits and Health Authority inspections
Seniority
Mid-level, hands-on IC
