Senior Director, Regulatory Compliance, Advanced Therapies

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Johnson & Johnson is the worlds 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 126500 people worldwide deployed in more than 250 operating companies in 60 countries.

Position Summary:

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.

Major Duties & Responsibilities:

• 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 Tcritical 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 improvement initiatives to reduce high-risk findings shorten time-to-release and strengthen vendor performance.

Education Requirement

• Minimum of a Bachelors Degree in life sciences engineering pharmacy or related field. Advanced degree preferred.

Professional Experience

• Minimum of 10 years of relevant experience with Advanced Therapies and/or Biologics with demonstrated GMP compliance leadership for autologous cell therapies (CAR T preferred).

• Experience in Quality Operations and GMP compliance across commercial and clinical manufacturing settings.

• Demonstrated track record leading or co-leading major health authority inspections and negotiating remediation.

• Experience leading cross-functional compliance activities including audits CAPA/Deviation programs vendor oversight and inspection readiness.

• Experience as an Investigator for the US FDA is extremely valuable.

Knowledge Skills and Abilities

• Extensive experience managing all facets of Quality and Regulatory Compliance within a global environment for cell therapy manufacturing.

• Deep understanding of the pharmaceutical regulated healthcare environment and modality-specific risks for CAR T (leukapheresis viral vector handling transduction cryopreservation logistics chain-of-identity).

• Proven experience collaborating with or working for regulatory agencies (e.g. US FDA EMA MHRA) and achieving positive compliance outcomes.

• Strong ability to establish partnerships manage complexity influence without direct authority and negotiate trade-offs across organizations.

• Demonstrated experience designing or managing risk-based oversight programs spanning multiple businesses and contract partners.

• Strong executive presentation and stakeholder management skills.

• Ability to balance technical product/process knowledge with a compliance-driven perspective and sound business judgment.

People Management Experience

• Candidates must have a minimum of 8 years of successfully managing people including building and developing technical compliance teams.

Preferred Qualifications

• Bachelor of Science degree preferred; advanced degree desirable.

• Industry Experience:

• Demonstrated experience in providing remediation support for organizations subject to FDA oversight is preferred.

• Prior background working with agencies such as the US FDA EMA or MHRA in the context of advanced therapies.

• Demonstrated practical expertise in Advanced Therapies operations.

Travel on the Job: up to 40% domestically and internationally.

The position may not be performed remotely.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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