Associate Director, Sterility Quality & Compliance

BeiGene, Ltd.; Northern (KY); Hybrid; USD 134,000 - 184,000; Full time

Job summary

BeOne Medicines Ltd is seeking an Associate Director of Sterility Quality Assurance to lead the site’s sterility program, ensuring cGMP compliance and a sustained state of control in aseptic manufacturing. The role partners with manufacturing, QC Microbiology, Engineering, Validation, MSAT, and Regulatory Affairs to protect product quality and patient safety.

The candidate will own the Contamination Control Strategy, oversee environmental monitoring, investigations, CAPA management, and

Qualifications

• Bachelor of Science in a relevant field with 8+ years of microbiology/QA experience in pharma/biotech.
• Master’s degree desired with 6+ years of related scientific experience.
• Experience leading regulatory inspections and Contamination Control Strategy ownership.

Responsibilities

• Lead and continuously improve the site sterility assurance and contamination control programs in alignment with cGMP, FDA requirements, EU GMP Annex 1, and applicable global standards.
• Own or co-own the Contamination Control Strategy, including risk assessment, governance, performance monitoring, periodic review, and remediation of identified gaps.
• Provide technical oversight for aseptic processing, environmental and personnel monitoring, cleanroom controls, cleaning and disinfection, critical utilities, sterilization and depyrogenation, sterile filtration, isolator systems, and container closure integrity.
• Lead or support aseptic process simulations/media fills, operator qualification and requalification, gowning certification, cleanroom qualification, and validation lifecycle activities.
• Direct investigations of sterility, microbiological, environmental, and aseptic-process events; ensure robust root cause analysis, scientifically justified impact assessments, and effective CAPAs.

Skills

Sterility Assurance

Aseptic Processing

Environmental Monitoring

Contamination Control

CAPA Management

Regulatory Inspections

Leadership

Cross-functional

Education

Bachelor of Science

Master’s Degree

Tools

MS Office

Job description

BeOne Medicines Ltd is seeking an Associate Director of Sterility Quality Assurance to lead the site’s sterility program, ensuring cGMP compliance and a sustained state of control in aseptic manufacturing. The role partners with manufacturing, QC Microbiology, Engineering, Validation, MSAT, and Regulatory Affairs to protect product quality and patient safety.

The candidate will own the Contamination Control Strategy, oversee environmental monitoring, investigations, CAPA management, and