Global CAR-T GMP Compliance Leader

• 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

Requirements

• 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.

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Hard Skills

• GMP compliance
• risk-based audit
• CAPA governance
• deviation investigations
• root-cause analysis
• health authority inspections
• autologous cell therapy
• CAR-T manufacturing processes
• quality operations
• vendor oversight

Soft Skills

• leadership
• strategic thinking
• decision making
• executive communication
• stakeholder management
• cross-functional integration
• team development
• technical complexity translation
• prioritization
• trend analysis

Certifications & Qualifications

• Bachelor’s Degree
• Advanced degree