Senior Director, Next Gen CAR-T Quality Leader
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Spring House • Pennsylvania • United States
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Job Level
About the role
- Provide strategic leadership for the Bi-Car / Next-Gen cell therapy program from a Quality perspective, ensuring alignment with overall business goals, product pipeline needs, and long-term enterprise objectives.
- Co-develop, with Operations and cross-functional technical functions, the comprehensive E2E quality strategy for automated and robotic manufacturing and QC testing platforms.
- Establish the long-range vision and roadmap for manufacturing and QC innovation, scalability, and technology advancement in close partnership with R&D and Pilot Plant investments.
- Serve as primary Quality accountable for the end-to-end program lifecycle—from feasibility through full-scale commercial operations.
- Collaborates with site leaders and cross-functional global teams to optimize supply chain access, expand manufacturing capacity, and ensure timely delivery of high-quality products globally.
- Lead the Quality review & approval for the design, build, and startup of two (2) state-of-the-art next-generation cell therapy facilities, in US and EU .
- Ensure all required quality systems, technologies, and digital platforms are development-ready and integrated for commercial deployment.
- Identify, manage, and mitigate program risks; establish and track KPIs to ensure transparency, performance, and timely achievement of investment key event milestones.
- Partner closely with Manufacturing, R&D, Supply Chain, Regulatory, and Commercial to align on dependencies, address cross-functional issues, and ensure smooth progression from clinical to commercial operations.
Requirements
- Bachelors degree in Pharmacy, Engineering, Chemistry, Microbiology or related scientific / engineering discipline required
- At least 12 years working experience in the pharmaceutical industry with demonstrated capability in Quality leadership roles.
- Minimum of 12 years of Quality Assurance experience related to manufacturing is required; Experience launching facilities is required
- Deep expertise in biologics and/or CAR-T manufacturing, including Quality Management Systems and cGMP operations required.
- Proven leadership in automated, next-generation, or cell therapy manufacturing technologies highly preferred.
- Extensive knowledge of chemical, biochemical and microbiological concepts is required.
- Strong people leadership with a track record of building, developing, and retaining high-performing Quality teams (QA, QC, Systems, etc.) is required.
- Comprehensive regulatory, technical, and cGMP knowledge (US/EU), including experience hosting global health authority inspections is required.
- Demonstrated success leading commercial cGMP operations and ensuring inspection readiness is required.
- Extensive understanding of chemical, biochemical, and microbiological principles; experience with aseptic processing (ISO 5) is required.
- Fluent in English, written and spoken.
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality AssuranceQuality Management SystemscGMP operationsautomated manufacturing technologiescell therapy manufacturingaseptic processingKPI trackingrisk managementbiologicsmicrobiological concepts
Soft skills
strategic leadershippeople leadershipcross-functional collaborationteam buildingcommunicationproblem-solvingperformance managementstakeholder engagementinnovationorganizational alignment