Senior Director, CAR T GMP Compliance – Advanced Therapy Platform

Responsibilities

• Serve as the technical compliance authority for CAR‑T GMP processes and controls across the global network
• Define and lead a global CAR‑T compliance strategy, aligned to IM Compliance objectives and IMQ priorities
• Establish and maintain minimum compliance and technical standards for CAR‑T critical activities
• Maintain continuous inspection readiness across all internal and external partners
• Lead inspection strategy, mock inspections, readiness assessments, and executive briefings
• Act as primary or co‑lead in interactions with regulatory authorities (FDA, EMA, MHRA, PMDA)
• Design and lead a risk‑based audit program across the CAR‑T ecosystem
• Oversee CAPA effectiveness verification and trend analysis to prevent recurrence
• Lead proactive identification and prioritization of GMP risks across CAR‑T operations
• Ensure robust governance over deviations and investigations, root‑cause analysis quality, and CAPA design and effectiveness
• Act as a cross‑functional integrator, ensuring alignment across IM:
  Compliance Quality Manufacturing Supply Chain Clinical Operations Regulatory Affairs
• Build and lead a high‑performing, technically strong compliance team

• Bachelor’s Degree in life sciences, engineering, pharmacy, or related field
• Advanced degree preferred
• Minimum 15+ years of experience in Advanced Therapies and/or Biologics GMP compliance
• Demonstrated leadership experience in autologous cell therapy (CAR‑T strongly preferred)
• Proven track record leading or co‑leading health authority inspections and remediation
• Experience across:
  Compliance Oversight, Quality Operations, Audit programs, CAPA/Deviation governance, Vendor/CMO oversight
• Experience with health authorities (FDA, EMA, MHRA) highly valued
• Prior FDA Investigator experience preferred
• Deep expertise in CAR‑T manufacturing processes and modality‑specific risks
• Strong ability to translate technical complexity into clear compliance decisions
• Demonstrated strength in strategic thinking, decision making under uncertainty, executive communication, and stakeholder management
• Minimum 10+ years leading and developing high‑performing teams
• Proven ability to build technical depth and accountability culture.