Senior Sterility Assurance Lead — Contamination Control

Regulatory Jobs; Hopewell (NJ); On-site; USD 134,000 - 184,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

Job summary

BeOne Medicines Ltd in Hopewell, NJ is seeking an Associate Director, Sterility Quality Assurance to lead the site sterility program and ensure compliance with cGMP and global standards. You will guide aseptic processing, environmental monitoring, cleanroom controls, and validation lifecycles while partnering with Regulatory Affairs and Manufacturing.

The role requires strategic leadership, strong technical judgment, and proven ability to drive CAPAs, investigations, and continuous improvement

Qualifications

• Bachelor of Science with 8+ years in microbiology or quality assurance in biotech/pharma.
• Master’s degree in a related field preferred.
• Experience leading regulatory inspections and Contamination Control Strategy ownership.
• Strong knowledge of aseptic processing, environmental monitoring, validation, CAPA, and risk management.
• Ability to lead cross-functional teams and communicate effectively.

Responsibilities

• Lead sterility assurance and contamination control programs.
• Own the Contamination Control Strategy and governance.
• Oversee aseptic processing, environmental monitoring, and cleanroom controls.
• Lead investigations of sterility and environmental events; drive CAPAs.
• Provide technical leadership and mentorship; support regulatory audits.

Skills

Sterility assurance

Aseptic processing

CAPA management

Regulatory inspections

Root cause analysis

Project management

Cross-functional leadership

Education

Bachelor of Science in Microbiology

Master’s degree in related field

Tools

MS Office

Job description

BeOne Medicines Ltd in Hopewell, NJ is seeking an Associate Director, Sterility Quality Assurance to lead the site sterility program and ensure compliance with cGMP and global standards. You will guide aseptic processing, environmental monitoring, cleanroom controls, and validation lifecycles while partnering with Regulatory Affairs and Manufacturing.

The role requires strategic leadership, strong technical judgment, and proven ability to drive CAPAs, investigations, and continuous improvement