Manager Quality Assurance
Core
Managing the quality management system for a microbiological analysis laboratory, ensuring compliance with regulations and internal standards while leading a QA team.
Role type
Manager, Quality Assurance
Builds
Compliance with GMP/GLP/ISO standards and validated microbiological testing results for pharma/medical device clients
Domain
Life Sciences / Biopharma / Microbiology
Deliverable
client delivery
Required skills
GMP, GLP, ISO standards, team leadership, regulatory compliance, audit management, supplier qualification, policy implementation
Preferred skills
KPI management, training and development, stakeholder communication
Technologies
Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS)
Responsibilities
Lead the QA department including hiring, performance reviews, and staff development; Maintain and update the quality management system; Review and release Certificates of Analysis (CoAs); Organize and follow up on external audits; Handle quality complaints; Approve specifications and research methods; Qualify and release personnel for critical tasks; Manage opiate administration records
Seniority
Manager, hands-on leadership
