Senior Director, Regulatory Compliance, Advanced Therapies

Johnson & Johnson•Raritan, NJ

50d

About The Position

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 MedTech, 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. Learn more at https://www.jnj.com Job Function: Legal & Compliance Job Sub Function: Enterprise Compliance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: 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

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
10 days Volunteer Leave – 32 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits