Senior Director, CAR T GMP Compliance (Autologous) – Advanced Therapy Platform

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Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America

Job Description:

Position Summary

The Senior Director, CAR‑T GMP Compliance is the global compliance leader and technical authority for autologous CAR‑T therapies across the Advanced Therapy platform. This role is accountable for ensuring robust, risk‑based, and inspection‑ready GMP compliance across internal sites, CMOs, apheresis centers, testing laboratories, and cold‑chain logistics partners.

As a member of the IM Compliance Leadership Team, this leader drives a process‑driven, expertise-enabled operating model, ensuring that compliance decisions are technically sound, consistently applied, and directly enable safe, timely, and reliable patient supply.

This role integrates across Quality, Manufacturing, Supply Chain, Clinical, Regulatory Affairs/CMC, and Corporate functions to anticipate and mitigate risk proactively, rather than reactively managing compliance issues.

Key Responsibilities:

1. Technical Authority & Compliance Strategy

• 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

2. Inspection Readiness & Health Authority Engagement

• 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), including:

  • Inspection response strategy

  • Evidence preparation

  • Remediation negotiation

• Ensure inspection learnings drive systemic improvements, not localized fixes

3. Risk-Based Audit & Oversight Program

• Design and lead a risk-based audit program across the CAR‑T ecosystem

• Oversee CAPA effectiveness verification and trend analysis to prevent recurrence

4. Risk Management, Investigations & CAPA Accountability

• 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

• Drive prevention of recurrence for critical risks

• Establish and enforce clear escalation triggers and decision pathways

5. Cross-Functional Integration & Decision Making

• Act as a cross-functional integrator, ensuring alignment across IM:

  • Compliance

  • Quality

  • Manufacturing

  • Supply Chain

  • Clinical Operations

  • Regulatory Affairs

• Co-own critical outcomes with site and platform leaders, including:

  • Inspection readiness

  • CAPA effectiveness

  • Risk mitigation execution

• Serve as a decision authority or co-decision maker for:

  • High-risk GMP events

  • Product quality vs. supply trade-offs

  • Critical compliance decisions impacting patient safety

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