Associate Director, GxP Compliance And Auditing (Biotech)

TL;DR

Associate Director, GxP Compliance and Auditing (Biotech): Leading the development and implementation of global GxP compliance and auditing programs with an accent on inspection readiness, supplier quality management, and regulatory intelligence. Focus on driving risk-based methodologies, managing cross-site quality systems, and fostering a proactive compliance culture across manufacturing facilities.

Location: Must be based in Bridgewater, NJ (Hybrid role)

Company

A global biotechnology company dedicated to developing advanced cell therapies for life-threatening diseases.

What you will do

• Lead and own global GxP compliance and auditing programs, serving as the Global Business Process and System Owner.
• Drive the Inspection Readiness Program to prepare sites for Health Authority and external party inspections.
• Manage internal and external audit schedules, including vendor and third-party audits, and oversee CAPA responses.
• Oversee the Quality Systems Management Review Program and monitor key quality metrics.
• Execute the GxP Regulatory Intelligence Program to identify and implement applicable regulatory changes.
• Partner with operational groups and network sites to foster a proactive compliance culture and provide QA advice.

Requirements

• Bachelor’s degree in a scientific or technical discipline required (Advanced degree preferred).
• Minimum 12 years of relevant GxP work experience in Quality, Compliance, or Regulatory functions within the biopharmaceutical industry.
• Minimum 5 years of leadership experience with proven success in matrixed organizations.
• Deep expertise in global GxP regulations (21 CFR, ICH Q10, EU GDP/GMP, PIC/S, etc.).
• Proven experience hosting regulatory inspections and leading enterprise-level compliance programs.
• Ability to travel 20% of the time for on-site audits and inspections.

Culture & Benefits

• Opportunity to work on cutting-edge cell therapy platforms.
• Collaborative environment focused on patient-centric innovation.
• Comprehensive benefits package for permanent full-time employees.
• Commitment to professional growth and cross-functional partnership.