Senior Director, Next Gen CAR-T Quality Leader

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

Job Function:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

POSITION SUMMARY:

The Senior Director, Next Gen CAR-T Quality Leader is a strategic Quality leadership role responsible for shaping, executing, and overseeing the end-to-end Quality strategy for Johnson & Johnson's next-generation CAR-T manufacturing and QC testing platform. This leader will guide the design, implementation, and commercialization of highly automated, robotics-enabled manufacturing and QC testing systems to support a transformative new cell therapy product. The role serves as the primary platform Quality responsible leader, accountable for end-to-end Quality oversight from clinical development through full commercial launch of two global manufacturing locations (US and Europe), representing a combined investment of $2.2B. The Senior Director, Next Gen CAR-T Quality leader will work closely with a cross-functional governance structure-including Manufacturing, R&D, Supply Chain, Regulatory, and Commercial-to ensure seamless program execution, robust risk mitigation, and delivery of all program milestones.

This role also ensures compliance with cGMP regulations and standards and Innovative Medicines quality requirements, while establishing and maintaining robust Quality standards and systems across Next Gen CAR-T sites. The leader develops and executes multi-year long-term Quality strategies, driving a reliable supply of high-quality products for both clinical and commercial use through the Advanced Therapies Supply Chain. Additionally, this role will manage a global team of QA & QC professionals, fostering a culture of excellence and continuous improvement.

This leader will interface regularly with senior executives, providing clear and proactive communication on program progress, challenges, and strategic decisions. They will champion a culture of innovation, compliance, performance, and inclusion while building the advanced Quality capabilities needed to support the future of cell therapy manufacturing at Johnson & Johnson.

MAJOR DUTIES & RESPONSIBILITIES:

Strategic Quality Leadership for Next Gen CART Manufacturing

• 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.

Program Delivery, Technology Readiness & Cross-Functional Partnership

• 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.

Quality Governance, Leadership Interface & People Leadership

• Serve as the primary Quality liaison to senior leadership, providing routine updates on progress, risks, mitigation actions, and strategic decisions.

• Represent Quality in cross-functional governance bodies and investment decision reviews.

• Leads and develops a diverse, high-performing matrix organization across the US and Europe. Build future Quality CART capabilities in analytics, digital, and advanced technologies; mentor and sponsor key talent across the network.

• Drives the achievement of annual goals, guided by Our Credo and leadership principles, emphasizing inclusion, collaboration, and mission-driven performance.

• Ensures continuous training and development of Quality personnel to meet evolving business and regulatory needs.

• Ensures the Quality department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Champion organizational change and continuous improvement to deliver Next Gen CART products.

Site Quality Management Oversight

• Provide overarching site-level QA and QC leadership for all activities supporting clinical and commercial manufacturing across the Next Gen network, ensuring compliance with J&J policies and procedures.

• Establish and maintain robust QMS requirements in alignment with Innovative Medicine Quality standards and global regulatory requirements and expectations.

• Guides QA & QC teams to ensure the effectiveness of the Quality Management System (QMS) and GMP compliance across all clinical / commercial manufacturing activities.

• Ensure inspection readiness, consistent application of quality standards, and timely escalation of quality issues.

• Lead and participate in Quality Management Reviews / Quality Council meetings, evaluate product/process performance, and drive continuous improvement initiatives.

• Oversee compliance with global health authority regulations; interpret emerging regulatory trends and advise leadership on implications.

• Provides expertise on global health authority regulations, guiding interpretation and application to ensure ongoing compliance.

• Acts as a primary Quality representative during health authority inspections, leading internal and regulatory audits and fostering strong regulator relationships.

• Approves and monitors suppliers, contract manufacturers, and outsourced GMP activities to uphold quality standards.

Network Harmonization

• Collaborates with the VP, IMSC Quality, Advanced Therapies, and other site Quality Heads and Platform Quality leaders to ensure harmonized quality practices, systems, and procedures across all next-gen CAR-T sites.

• Drives the establishment and maintenance of standardized quality practices across the network, supporting global compliance and operational efficiency.

• Drive right-first-time culture; improve operational efficiency, reliability, and deviation reduction.

• Develop and manage operating budgets; optimize turnaround times and ensure overall business performance.

Other duties may include:

• Attendance and representation at external industry forums for professional development and advancement

• Special projects based on business needs

REQUIRED QUALIFICATIONS:

Required Minimum Education :

• 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.

Required Years of Related Experience:

• Minimum of 12 years of Quality Assurance experience related to manufacturing Is required; Experience launching facilities is required

Required Knowledge, Skills and Abilities :

• 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

Preferred Knowledge, Skills and Abilities :

• Strategic thinker able to manage complexity and drive transformational change.

• Strong prioritization, risk assessment, and decision-making capabilities in fast-changing environments.

• Effective influencer with strong negotiation, communication, and conflict-resolution skills.

• Continuous improvement mindset with strong business acumen, including budget management.

• Ability to communicate clearly at all organizational levels and with global regulatory authorities.

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 ( [email protected] ) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Inclusive Leadership, Internal Auditing, ISO 9001, Leadership, Leading Change, Process Optimization, Quality Control (QC), Quality Processes, Quality Standards, Quality Validation, Resource Planning, Risk Management, Standard Operating Procedure (SOP), Tactical Planning