Sterility Assurance Lead, Quality & Compliance

BeOne Medicines; Hopewell (NJ); On-site; USD 134,000 - 184,000; Full time

Benefits offered by this job

Medical Benefits

Dental Insurance

Vision Insurance

401(k)

Life Insurance

Paid Time Off

Wellness Programs

Job summary

BeOne Medicines in Hopewell, NJ seeks an Associate Director, Sterility Quality Assurance to lead the site sterility program and ensure compliance with cGMP, FDA and EU standards. This role serves as the SME for aseptic processing and contamination control and collaborates across Manufacturing, QC Microbiology, Validation, and Regulatory Affairs.

The position emphasizes strategic risk assessment, lifecycle management of the Contamination Control Strategy, and providing technical leadership,

Qualifications

• Bachelor of Science degree in a relevant field with 8+ years of microbiology/quality assurance experience in FDA-regulated biotech/pharma.
• Master’s degree and 6+ years of related scientific experience preferred.
• Experience leading regulatory inspections and owning a Contamination Control Strategy.
• Advanced knowledge of aseptic processing, environmental monitoring, and CAPA management.
• Strong leadership, communication, and project-management skills.

Responsibilities

• Lead site sterility assurance and contamination control programs in line with cGMP, FDA, and EU Annex 1.
• Own or co-own the Contamination Control Strategy governance and remediation of gaps.
• Provide technical oversight for aseptic processing, cleanroom controls, sterilization, and related validation activities.
• Direct investigations of sterility and environmental events with robust root-cause analysis and CAPAs.
• Serve as SME during regulatory inspections, audits, and process validations.

Skills

Attention to detail

Analytical thinking

Problem solving

Project management

Communication

Self-motivated

IT skills

Education

Bachelor of Science

Master’s degree preferred

Tools

Microsoft Office

Microsoft Project

Outlook

Job description

BeOne Medicines in Hopewell, NJ seeks an Associate Director, Sterility Quality Assurance to lead the site sterility program and ensure compliance with cGMP, FDA and EU standards. This role serves as the SME for aseptic processing and contamination control and collaborates across Manufacturing, QC Microbiology, Validation, and Regulatory Affairs.

The position emphasizes strategic risk assessment, lifecycle management of the Contamination Control Strategy, and providing technical leadership,