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