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

Johnson & Johnson Innovative Medicine•Horsham, PA

6d•Hybrid

About The Position

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.

Requirements

Bachelor’s Degree in life sciences, engineering, pharmacy, or related field
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
Strong ability to influence without authority across global, matrixed organizations
Strong ability to balance patient safety, compliance, and supply continuity
Demonstrated strength in strategic thinking
Demonstrated strength in decision making under uncertainty
Demonstrated strength in executive communication and stakeholder management
Minimum 10+ years leading and developing high-performing teams
Proven ability to build technical depth and accountability culture

Nice To Haves

Advanced degree preferred

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), including: Inspection response strategy, Evidence preparation, Remediation negotiation
Ensure inspection learnings drive systemic improvements, not localized fixes
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
Drive prevention of recurrence for critical risks
Establish and enforce clear escalation triggers and decision pathways
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
Build and lead a high-performing, technically strong compliance team
Establish a culture of: Transparency and early escalation, Fact-based, risk-based decision making, Accountability for outcomes, not just activities
Develop team capabilities aligned future-state needs

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year