Director, Sterility Assurance & Aseptic Quality

BeiGene, Ltd.; Hopewell (VA); Vor Ort; USD 134.000 - 184.000; Vollzeit

Zusammenfassung

BeOne Medicines Ltd. seeks an Associate Director of Sterility Quality Assurance to lead site sterility programs at the Hopewell location, ensuring compliant, scientifically sound operations in aseptic manufacturing.

You will partner across Manufacturing, QA Microbiology, Engineering, and Regulatory Affairs to protect product quality and patient safety. The role requires extensive experience in aseptic processing, contamination control, and regulatory readiness, with strong leadership,

Qualifikationen

• Bachelor of Science degree and 8+ years of relevant experience in microbiology or biological quality assurance within FDA-regulated biotech/pharma.
• Master’s degree and 6+ years of related experience preferred.

Aufgaben

• Lead site sterility assurance and contamination control programs.
• Own Contamination Control Strategy governance and risk management.
• Oversee aseptic processing, environmental monitoring, cleanroom controls, sterilization, and container closure integrity.
• Direct investigations of sterility and environmental events; ensure robust CAPAs.
• Regulatory inspections support and technology transfer oversight.

Kenntnisse

Aseptic processing

Contamination control

Regulatory inspections

Quality risk management

Project management

Ausbildung

Bachelor of Science in microbiology/biology

Master’s degree (preferred)

Tools

MS Office

Jobbeschreibung

BeOne Medicines Ltd. seeks an Associate Director of Sterility Quality Assurance to lead site sterility programs at the Hopewell location, ensuring compliant, scientifically sound operations in aseptic manufacturing.

You will partner across Manufacturing, QA Microbiology, Engineering, and Regulatory Affairs to protect product quality and patient safety. The role requires extensive experience in aseptic processing, contamination control, and regulatory readiness, with strong leadership,