Senior Director, Next Gen CAR-T Quality Leader
OneTrust
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.
- Collaborate 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.
- Ensure inspection readiness, consistent application of quality standards, and timely escalation of quality issues.
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.
- At least 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 & Tools
Quality AssuranceQuality Management SystemscGMP operationsautomated manufacturing technologiescell therapy manufacturingaseptic processingKPI trackingrisk managementbiologicsmicrobiological concepts
Soft Skills
strategic leadershippeople leadershipcross-functional collaborationcommunicationproblem-solvingteam developmentstakeholder managementperformance trackinginspection readinessdecision making