Johnson & Johnson Innovative Medicine · 7 hours ago
Senior Director, Next Gen CAR-T Quality Leader
Spring House, PA
Full-time
Onsite
Director/Executive
12+ years expJohnson & Johnson is a leader in healthcare innovation, committed to preventing, treating, and curing complex diseases. The Senior Director, Next Gen CAR-T Quality Leader will be responsible for overseeing the Quality strategy for CAR-T manufacturing and QC testing, ensuring compliance and driving innovation across the organization.
Pharmaceuticals
Responsibilities
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
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
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
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
Qualification
Required
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
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
Proven leadership in automated, next-generation, or cell therapy manufacturing technologies highly preferred
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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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