Executive Director, QA Sterility Assurance
Regeneron
August 25, 2026
On-site
East Greenbush, NY
Operations
Discover Your Role
- Design, implement, and continuously improve a holistic Contamination Control Strategy (CCS) for GMP contamination control across aseptic and low-bioburden manufacturing.
- Provide expert direction for environmental monitoring (EM), cleanroom classification, personnel qualification, gowning practices, and aseptic process simulation (media fill) performance.
- Drive root cause investigations and risk assessments for microbial excursions, sterility failures, and EM deviations; ensure timely science-based CAPA.
- Track CCS performance using operational metrics (e.g., EM trends, excursion rates, media fill success rates) and drive continuous improvement.
- Embed quality risk management tools (e.g., FMEA, contamination risk mapping) to identify and mitigate contamination vectors.
- Stay current on regulatory expectations (e.g., EU Annex 1, FDA aseptic processing guidance, USP, PIC/S, ISO 14644) and integrate emerging requirements.
- Partner with QA Operations, Manufacturing, Facilities/Engineering, and Microbiology Lab to translate strategy into floor-level execution.
- Serve as the senior decision-maker and represent the company as the subject matter authority with internal leadership, regulators, and partners.
This Role Requires
- Bachelor’s degree in a relevant scientific field (advanced degree preferred) or equivalent experience.
- Progressive experience in pharmaceutical/biopharmaceutical microbiology, sterility assurance, or contamination control, including aseptic leadership: Executive Director 18+ years (Senior Director 15+).
- Deep aseptic and low-bioburden operational expertise (cleanroom design/classification, HVAC principles, personnel/material flow, gowning qualification, aseptic technique).
- Hands-on CCS ownership (EM design/trending/risk-based site selection) and media fill design/execution/failure investigation.
- Track record leading root cause/deviation management/CAPA; strong QRM application (FMEA, fishbone, risk mapping).
- Inspection experience representing microbiology/contamination control to health authorities (FDA/EMA/MHRA).
- Strong people leadership and communication; sound judgment in high-stakes decisions.
Application Instructions
- Apply now.
- Design, implement, and continuously improve a holistic Contamination Control Strategy (CCS) for GMP contamination control across aseptic and low-bioburden manufacturing.
- Provide expert direction for environmental monitoring (EM), cleanroom classification, personnel qualification, gowning practices, and aseptic process simulation (media fill) performance.
- Drive root cause investigations and risk assessments for microbial excursions, sterility failures, and EM deviations; ensure timely science-based CAPA.
- Track CCS performance using operational metrics (e.g., EM trends, excursion rates, media fill success rates) and drive continuous improvement.
- Embed quality risk management tools (e.g., FMEA, contamination risk mapping) to identify and mitigate contamination vectors.
- Stay current on regulatory expectations (e.g., EU Annex 1, FDA aseptic processing guidance, USP, PIC/S, ISO 14644) and integrate emerging requirements.
- Partner with QA Operations, Manufacturing, Facilities/Engineering, and Microbiology Lab to translate strategy into floor-level execution.
- Serve as the senior decision-maker and represent the company as the subject matter authority with internal leadership, regulators, and partners.
This Role Requires
- Bachelor’s degree in a relevant scientific field (advanced degree preferred) or equivalent experience.
- Progressive experience in pharmaceutical/biopharmaceutical microbiology, sterility assurance, or contamination control, including aseptic leadership: Executive Director 18+ years (Senior Director 15+).
- Deep aseptic and low-bioburden operational expertise (cleanroom design/classification, HVAC principles, personnel/material flow, gowning qualification, aseptic technique).
- Hands-on CCS ownership (EM design/trending/risk-based site selection) and media fill design/execution/failure investigation.
- Track record leading root cause/deviation management/CAPA; strong QRM application (FMEA, fishbone, risk mapping).
- Inspection experience representing microbiology/contamination control to health authorities (FDA/EMA/MHRA).
- Strong people leadership and communication; sound judgment in high-stakes decisions.
Application Instructions
- Apply now.