Sr. Manager - Microbiology
Core
Lead a team of supervisors and department leads responsible for microbiology testing of raw materials and finished goods, ensuring compliance with GMP/GLP and regulatory standards.
Role type
Senior Manager, Microbiology Quality
Builds
Microbiology testing processes and compliance frameworks for sterile manufacturing products
Domain
Healthcare / Medical Devices / Sterile Manufacturing
Required skills
Microbiology testing techniques, GMP/GLP compliance, team leadership, regulatory knowledge (USP/FDA/ISO), continuous improvement, budget management, coaching and training
Preferred skills
Bachelor's degree in Biology or Microbiology, experience in aseptic or sterile manufacturing sites
Technologies
Bioburden testing, microbial identification, endotoxin testing, solution particulate matter detection
Responsibilities
Develop and manage a team of microbiology testing supervisors; supervise product testing procedures for bioburden, microbial identification, endotoxin, and solution particulate matter; ensure compliance with GMP and GLP; coordinate with cross-functional teams on testing requirements and change controls; collaborate with Quality Assurance on deviations and investigations; participate in internal and external audits and interface with regulatory agencies; develop KPIs and action plans for process efficiency; lead continuous improvement projects; manage department budget and report on overspend; coach, train, and develop subordinates; maintain a clean and safe work area using 6S principles.
Seniority
Senior, hands-on IC with leadership responsibilities