QMS Manager
EPM Scientific · Boca Raton, FL · 2 mo ago
On-siteQuality AssuranceFull-time
About the role
A growing pharmaceutical manufacturer is seeking a Head of Microbiology to lead microbiology operations at a sterile manufacturing facility.
Key Responsibilities
- Lead and develop the microbiology function
- Oversee environmental monitoring and sterility assurance programs
- Manage sterility, bioburden, endotoxin, and microbial limit testing activities
- Support contamination investigations, root cause analysis, and CAPAs
- Lead media fill and aseptic process simulation activities
- Ensure inspection readiness and regulatory compliance
- Partner with Manufacturing, QA, QC, Validation, and Engineering teams
- Manage microbiology laboratory operations and personnel
Qualifications
- BS in Microbiology, Biology, Biotechnology, Pharmacy, or related discipline
- 12+ years of pharmaceutical microbiology experience
- Leadership experience within GMP-regulated manufacturing
- Strong background in sterile manufacturing and aseptic processing
- Experience supporting FDA inspections and audit activities
- Expertise in environmental monitoring and sterility assurance