Senior Director, Regulatory Compliance, Advanced Therapies

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Legal & Compliance

Enterprise Compliance

People Leader

Raritan, New Jersey, United States of America

Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the pharmaceutical, and medical technologies professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries.

Reporting to the Vice President, Innovative Medicine Regulatory Compliance Leader, this role leads a team of compliance professionals and is part of the IM Compliance Leadership Team. This Senior Director is the GMP compliance leader for CAR T-cell therapies (autologous) across the Advanced Therapy Platform and is accountable for inspection readiness, audit programs, CAPA/deviation reviews, and maintaining a robust compliance program.

The position partners closely with Quality, Supply Chain, Regulatory Affairs, R&D, Clinical Operations, Manufacturing, and Corporate Compliance to enable safe, timely patient supply while minimizing regulatory and patient risk.

• Define and lead a global GMP compliance strategy specific to CAR T-cell products that aligns with IM Compliance objectives and Janssen business priorities.
• Translate strategy into an annual compliance roadmap with measurable milestones, resource plans, and outcome-based KPIs tied to patient supply continuity and inspection readiness.
• Maintain continuous inspection readiness across internal sites, CMOs, apheresis centers and logistics partners; lead inspection planning, mock inspections, readiness assessments, cross-functional briefings and corrective action negotiations.
• Act as primary or co-lead for interactions with health authorities (e.g., US FDA, EMA, MHRA, PMDA), including drafting inspection responses, preparing submission-related GMP evidence, and negotiating remediation plans.
• Design and direct a risk-based audit program covering manufacturing sites, CMOs, and cold-chain logistics providers; oversee audit scope, execution, findings resolution, CAPA effectiveness verification, and trend analysis.
• Lead identification, assessment and prioritized mitigation of GMP risks across CAR T operations, balancing patient safety, regulatory obligations and product supply continuity.
• Oversee timely, thorough investigations, root-cause analyses and closure of deviations, nonconformances and CAPAs. Ensure verification of CAPA effectiveness and use of trending to prevent recurrence of critical events (identity, sterility, potency).
• Ensure QMS controls for CAR T–critical activities: assay validation (potency), viral vector testing and release, in-process and hold-time controls (including cryopreservation), process validation, equipment/facility qualification, and controlled change management.
• Provide compliance oversight during technology transfers and scale-up, ensuring appropriate validation, qualification and change control to support reliable product supply.
• Serve as the GMP compliance SME in cross-functional teams (Quality, Manufacturing, Supply Chain, Clinical, Regulatory Affairs, Pharmacovigilance) advising on regulatory implications of technical and business decisions.
• Provide compliance input for regulatory filings and pre-submission meetings with respect to CMC/GMP readiness, inspection history, and remedial actions.
• Build and lead a high-performing CAR T compliance team;
  Promote a culture of quality-first decision making, transparent escalation and continuous improvement.
• Drive continuous…