Associate Director, QC Compliance - Drive Quality

BeiGene; Hopewell (VA); On-site; USD 134,000 - 184,000; Full time

Job summary

BeOne Medicines Ltd. is seeking an Associate Director, QC Compliance in Hopewell, NJ to lead QC compliance programs and audits, ensuring FDA/EU regulatory alignment. You will guide investigations of OOS/OOT/OOE, develop CAPA plans, and mentor staff while partnering with QA, Regulatory Affairs, and Manufacturing.

The role requires 8+ years in FDA-regulated biotech/pharma, strong cGMP knowledge, and 5+ years of managerial experience. Travel ~20% and a robust benefits package are included.

Qualifications

• Bachelor of Science degree with 8+ years in FDA-regulated biotech/pharma manufacturing.
• Master’s degree preferred with 6+ years of related scientific experience.
• 5+ years of managerial experience leading teams or programs.
• Extensive knowledge of cGMP/EU GMP regulations, especially for large molecule manufacturing.

Responsibilities

• Develop, implement, and maintain QC compliance programs aligned with regulatory standards and internal policies.
• Lead investigations for OOS, OOT, and OOE with thorough evaluation and cGMP adherence.
• Prepare and write SOPs, compliance reports, deviation and CAPA records, and change control impact assessments.
• Lead the establishment of a QC compliance monitoring program and participate in GMP audits.
• Collaborate with QA, Regulatory Affairs, Manufacturing, and QA to support regulatory submissions and compliance initiatives.
• Mentor and develop QC compliance staff to build a high-performing team.
• Participate in risk assessments and assist in CAPA planning to address compliance issues.
• Ensure training and communication of compliance standards across the QC lab.

Skills

Quality assurance leadership

GMP/cGMP knowledge

Regulatory inspections/audits

Project management

Communication skills

Education

Bachelor of Science degree

Master's degree preferred

Tools

Veeva

ThermoScientific LIMS

MS Office

Job description

BeOne Medicines Ltd. is seeking an Associate Director, QC Compliance in Hopewell, NJ to lead QC compliance programs and audits, ensuring FDA/EU regulatory alignment. You will guide investigations of OOS/OOT/OOE, develop CAPA plans, and mentor staff while partnering with QA, Regulatory Affairs, and Manufacturing.

The role requires 8+ years in FDA-regulated biotech/pharma, strong cGMP knowledge, and 5+ years of managerial experience. Travel ~20% and a robust benefits package are included.