Associate Director, QC Sterility Assurance
Associate Director, QC Sterility Assurance
Location: Pennsylvania (On-site)
We're partnering with a global biopharmaceutical manufacturing organization to hire a Sterility Assurance Associate Director to lead contamination control and microbial strategy at a complex sterile production site.
This is a senior Quality leadership role with direct people leadership and strong matrix influence across Manufacturing, Quality, and Technical Operations.
Key responsibilities:
- Own and maintain the site Contamination Control Strategy and sterility assurance systems
- Lead and develop a small team of sterility assurance / microbiology SMEs
- Serve as the site expert for microbial risk management and contamination investigations
- Lead and approve microbial risk assessments and investigation reports
- Drive training, coaching, and strong aseptic behaviors across the organization
- Partner cross‑functionally with Operations, QA, QC Micro, Engineering, Validation, Facilities, and MSAT
- Analyze EM and utilities data, identify trends, and implement robustness improvements
- Support new product, process, equipment, and facility design from a microbial risk perspective
- Oversee cleaning, disinfection, disinfectant qualification, gowning, and aseptic technique programs
- Act as the front‑room SME during regulatory inspections for contamination control topics
- Support modernization of QC microbiology methods, including rapid methods and automation
Background requirements:
- Bachelor's degree in a scientific or engineering field (advanced degree preferred)
- 10+ years of sterile pharma, biopharma, biologics, or vaccine manufacturing experience
(PhD considered with ~7+ years) - Strong experience with sterility assurance systems, contamination control, and microbial risk management
- Hands‑on exposure to process microbiology and/or QC microbiology
- Solid understanding of cGMP and regulatory expectations for sterile manufacturing
- Proven ability to lead cross‑functional initiatives and communicate complex technical topics clearly
Why consider this role:
- High‑visibility site leadership position with real ownership of contamination control strategy
- Opportunity to influence inspection readiness and long‑term microbial robustness at scale
- Blend of people leadership and deep technical impact
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