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Johnson & Johnson · 4 days ago

Senior Director, Regulatory Compliance, Advanced Therapies

Raritan, NJ

Full-time

Onsite

Director/Executive

$178K/yr - $307K/yr

10+ years exp

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. This Senior Director role leads a team of compliance professionals and is the GMP compliance leader for CAR T-cell therapies, accountable for inspection readiness, audit programs, and maintaining a robust compliance program.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

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

Qualification

GMP compliance leadershipAdvanced Therapies experienceRegulatory agency collaborationQuality Operations experienceRisk-based audit programInspection readinessCAPA/Deviation managementStakeholder managementExecutive presentation skillsTeam management

Required

Minimum of a Bachelor's Degree in life sciences, engineering, pharmacy or related field

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

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

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

Preferred

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

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 period10 days

Volunteer Leave – 32 hours per calendar year

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)