Senior Director, Regulatory Compliance, Advanced Therapies

Johnson & Johnson Innovative Medicine • Raritan, NJ

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About The Position

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. 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.

Requirements

• Minimum of a Bachelor’s Degree in life sciences, engineering, pharmacy or related field. Advanced degree preferred.
• 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.
• 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.
• Candidates must have a minimum of 8 years of successfully managing people, including building and developing technical compliance teams.

Nice To Haves

• Bachelor of Science degree preferred; advanced degree desirable.
• 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.

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

Benefits

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees