QC Compliance Lead, Associate Director

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. seeks an Associate Director, QC Compliance in Hopewell, NJ, to lead quality control compliance programs and ensure FDA/EU regulatory adherence. The role includes investigations, documentation, audits, and cross-functional collaboration to sustain a robust quality system.

The ideal candidate holds a B.S. in a related field with 8+ years in FDA-regulated pharma, and a Master’s degree is preferred.

Responsibilities

• Develop, implement, and lead QC compliance programs aligned with regulatory standards.
• Lead investigations for OOS, OOT, and OOE per cGMP and regulatory requirements.
• Oversee documentation: SOPs, deviation and CAPA records, change control impact assessments.
• Establish and monitor a QC compliance program; participate in GMP audits.
• Collaborate with QA, Regulatory Affairs, Manufacturing to support submissions and compliance.

Job description

BeOne Medicines Ltd. seeks an Associate Director, QC Compliance in Hopewell, NJ, to lead quality control compliance programs and ensure FDA/EU regulatory adherence. The role includes investigations, documentation, audits, and cross-functional collaboration to sustain a robust quality system.

The ideal candidate holds a B.S. in a related field with 8+ years in FDA-regulated pharma, and a Master’s degree is preferred.