Quality Assurance Manager
Core
Ensuring quality assurance support for manufacturing processes of pharmaceutical products, medical devices, cosmetics, combination products, and biologics, ensuring compliance from raw material inspection through final shipment.
Role type
Quality Assurance Manager
Builds
Compliance with corporate and governmental regulations for product, process, and system quality activities
Domain
Pharmaceutical and medical device manufacturing
Deliverable
client delivery
Required skills
Leadership of technical professionals, regulatory knowledge (FDA, EMA, ICH), GMP compliance, deviation investigation, CAPA management, quality metrics analysis, policy development
Preferred skills
Chemistry, Pharmacy, Biology, Microbiology, or Engineering degree; experience in Quality, Regulatory, Process Sciences, Manufacturing Operations; knowledge of product, process, equipment, and facilities
Technologies
None explicitly stated
Responsibilities
Provide direction to staff including hiring and performance feedback; direct development of Quality policies; maintain expertise on regulations; provide compliance leadership to the manufacturing site; interface with FDA and regulatory agencies; perform compliance assessments; review and approve deviation investigations; compile and communicate quality metrics to senior management
Seniority
Manager, strategic direction and tactical execution