Senior Director, CAR T GMP Compliance (Autologous) - Advanced Therapy Platform

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Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America

Job Description:

Position Summary

The Senior Director, CAR‑T GMP Compliance is the global compliance leader and technical authority for autologous CAR‑T therapies across the Advanced Therapy platform. This role is accountable for ensuring robust, risk‑based, and inspection‑ready GMP compliance across internal sites, CMOs, apheresis centers, testing laboratories, and cold‑chain logistics partners.

As a member of the IM Compliance Leadership Team, this leader drives a process‑driven, expertise-enabled operating model, ensuring that compliance decisions are technically sound, consistently applied, and directly enable safe, timely, and reliable patient supply.

This role integrates across Quality, Manufacturing, Supply Chain, Clinical, Regulatory Affairs/CMC, and Corporate functions to anticipate and mitigate risk proactively, rather than reactively managing compliance issues.

Key Responsibilities:

1. Technical Authority & Compliance Strategy

• Serve as the technical compliance authority for CAR‑T GMP processes and controls across the global network

• Define and lead a global CAR‑T compliance strategy, aligned to IM Compliance objectives and IMQ priorities

• Establish and maintain minimum compliance and technical standards for CAR‑T critical activities

2. Inspection Readiness & Health Authority Engagement

• Maintain continuous inspection readiness across all internal and external partners

• Lead inspection strategy, mock inspections, readiness assessments, and executive briefings

• Act as primary or co-lead in interactions with regulatory authorities (FDA, EMA, MHRA, PMDA), including:

• Inspection response strategy

• Evidence preparation

• Remediation negotiation

• Ensure inspection learnings drive systemic improvements, not localized fixes

3. Risk-Based Audit & Oversight Program

• Design and lead a risk-based audit program across the CAR‑T ecosystem

• Oversee CAPA effectiveness verification and trend analysis to prevent recurrence

4. Risk Management, Investigations & CAPA Accountability

• Lead proactive identification and prioritization of GMP risks across CAR‑T operations

• Ensure robust governance over deviations and investigations, root-cause analysis quality, and CAPA design and effectiveness

• Drive prevention of recurrence for critical risks

• Establish and enforce clear escalation triggers and decision pathways

5. Cross-Functional Integration & Decision Making

• Act as a cross-functional integrator, ensuring alignment across IM:

• Compliance

• Quality

• Manufacturing

• Supply Chain

• Clinical Operations

• Regulatory Affairs

• Co-own critical outcomes with site and platform leaders, including:

• Inspection readiness

• CAPA effectiveness

• Risk mitigation execution

• Serve as a decision authority or co-decision maker for:

• High-risk GMP events

• Product quality vs. supply trade-offs

• Critical compliance decisions impacting patient safety

6. People Leadership & Culture

• Build and lead a high-performing, technically strong compliance team

• Establish a culture of:

• Transparency and early escalation

• Fact-based, risk-based decision making

• Accountability for outcomes, not just activities

• Develop team capabilities aligned future-state needs

7. Accountability & Success Measures

• Sustained inspection readiness across all CAR‑T sites and partners

• Reduction in:

• Critical and major inspection findings

• Repeat observations

• Late-stage escalations

• Demonstrated CAPA effectiveness and recurrence prevention

• Increased use of leading indicators to proactively manage risk

• Reduced reliance on external consultants for compliance diagnostics

• Maintenance of patient supply continuity without compliance-driven disruptions

Required Qualifications:

Education

• Bachelor's Degree in life sciences, engineering, pharmacy, or related field

• Advanced degree preferred

Experience

• Minimum 15+ years of experience in Advanced Therapies and/or Biologics GMP compliance

• Demonstrated leadership experience in autologous cell therapy (CAR‑T strongly preferred)

• Proven track record leading or co-leading health authority inspections and remediation

• Experience across:

• Compliance Oversight

• Quality Operations

• Audit programs

• CAPA/Deviation governance

• Vendor/CMO oversight

• Experience with health authorities (FDA, EMA, MHRA) highly valued

• Prior FDA Investigator experience preferred

Knowledge, Skills & Capabilities

• Deep expertise in CAR‑T manufacturing processes and modality-specific risks

• Strong ability to:

• Translate technical complexity into clear compliance decisions

• Influence without authority across global, matrixed organizations

• Balance patient safety, compliance, and supply continuity

• Demonstrated strength in:

• Strategic thinking

• Decision making under uncertainty

• Executive communication and stakeholder management

People Leadership

• Minimum 10+ years leading and developing high-performing teams

• Proven ability to build technical depth and accountability culture

Reports to: Vice President, Innovative Medicine Regulatory Compliance

Travel: Up to 40% (global)

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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$178,000.00 - $307,050.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

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 period10 days

Volunteer Leave- 32 hours per calendar year

Military Spouse Time-Off- 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits