Senior Director, CAR T GMP Compliance – Advanced Therapy Platform

Johnson & Johnson

Senior Director for CAR‑T GMP Compliance overseeing compliance for autologous therapies at Johnson & Johnson. Leading global compliance strategy and ensuring inspection readiness across the CAR‑T ecosystem.

Posted 5/14/2026full-timeHorsham • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $178,000 - $307,050 per yearWebsite

About the role

Key responsibilities & impact

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
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)
Design and lead a risk-based audit program across the CAR‑T ecosystem
Oversee CAPA effectiveness verification and trend analysis to prevent recurrence
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
Act as a cross-functional integrator, ensuring alignment across IM: Compliance Quality Manufacturing Supply Chain Clinical Operations Regulatory Affairs
Build and lead a high-performing, technically strong compliance team

Requirements

What you’ll need

Bachelor’s Degree in life sciences, engineering, pharmacy, or related field
Advanced degree preferred
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
Deep expertise in CAR‑T manufacturing processes and modality-specific risks
Strong ability to translate technical complexity into clear compliance decisions
Demonstrated strength in strategic thinking, decision making under uncertainty, executive communication, and stakeholder management
Minimum 10+ years leading and developing high-performing teams
Proven ability to build technical depth and accountability culture.

Benefits

Comp & perks

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.
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
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GMP compliancerisk-based auditCAPA governancedeviation investigationsroot-cause analysishealth authority inspectionsautologous cell therapyCAR-T manufacturing processesquality operationsvendor oversight

Soft Skills

leadershipstrategic thinkingdecision makingexecutive communicationstakeholder managementcross-functional integrationteam developmenttechnical complexity translationprioritizationtrend analysis

Certifications

Bachelor’s DegreeAdvanced degree