Manager, Product & Client Quality
Core
Manage product quality reviews, client quality relations, and quality management systems to ensure regulatory compliance and operational excellence in a pharmaceutical/medical device environment.
Role type
Manager, Quality Management
Builds
Quality management systems, compliance reports, and client quality commitments
Domain
Life Sciences / Pharmaceutical / Medical Device
Required skills
Quality management systems (QMS), regulatory compliance (FDA QSR/cGMP, ISO 9001, ISO 13485), CAPA, risk analysis, FMEA, root cause analysis, audit support, team mentorship, continuous improvement (Lean, Six Sigma), stakeholder management, analytical problem-solving, quality software proficiency
Preferred skills
Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field
Technologies
TrackWise, Document Control Systems
Responsibilities
Strategically plan and prioritize Annual Product Quality Reviews (APRs); Coordinate and compile management review presentations; Author and manage reports, decisions, and action items arising from APQRs and management reviews; Support site Change controls, CAPAs and Deviations; Serve as the primary Quality representative for assigned clients; Monitor product quality trends, risks, and key performance metrics; Lead Quality Management System improvements and cross-functional process optimization
Seniority
Manager, hands-on leadership
