Director Product Quality Leader

The Cell Therapy Product Quality Leader (PQL) is a matrixed leader responsible for the end-to-end product quality strategy and lifecycle management of autologous, allogeneic, and in-vivo cell therapy products. This role will provide technical and compliance oversight for advanced therapeutic modalities, including, but not limited to, drug substance, drug product, viral delivery systems (e.g. LVV, AAV), and gene-edited cell therapy products from clinical stage through commercialization. This role requires deep technical and compliance expertise, strategic thinking, and cross-functional collaboration to ensure product quality, regulatory compliance, and lifecycle continuity are met and maintained. 

Main Responsibilities: 

• Serve as the Quality representative on the CMC Team and lead the Product Quality Team (PQT) sub-team 

• Serve as the single voice of Quality in liaising with the CMC Program Lead to communicate Quality deliverables, risks, changes, etc. 

• Develop and implement the overall Product Quality Strategy and phase-appropriate control strategies 

• Own and maintain lot release and stability specifications for advanced cell therapy modalities 

• Manage the full specification lifecycle - from clinical stage through commercial approval and post-approval maintenance 

• Support the design and execution of analytical comparability studies supporting process and product changes for advanced cell therapy modalities; ensure scientifically sound strategies and data-driven conclusions  

• Support the design and execution of process tech transfer and analytical method transfer protocols/reports for advanced cell therapy modalities 

• Oversee the stability program for advanced cell therapy modalities, in collaboration with Global Stability 

• Oversee annual product reviews for commercial products 

• Maintain the Product Quality Risk Register to identify, mitigate, and escalate issues related to manufacturing, analytical methods, or supply chain 

• Work cross-functionally to develop and implement platform approaches for specifications, comparability, and stability to enable consistent, scalable practices across multiple cell therapy products 

• Author and review CMC sections for global filings, including INDs, BLAs, and MAAs; manage responses to health authority queries 

• Stay current on emerging process & analytical technologies and evolving regulatory expectations 

• Partner closely with Process Development, Analytical Sciences, Supply Chain, Quality, Regulatory Affairs, Program Management, and other impacted stakeholders to ensure alignment with development milestones and commercial objectives 

• Acts as a Subject Matter Expert (SME) during health authority inspections (e.g., FDA, EMA) for product quality-specific inquiries 

• Review and evaluate major process changes to ensure no impact to product safety and efficacy 

Education, Qualifications, & Experience: 

• Bachelor’s or Advanced degree (MS/PhD preferred) in Life Sciences or Engineering (e.g., Biology, Biochemistry, Chemical Engineering) 

• 10+ years in the biotechnology or biopharmaceutical industry, with at least 3 - 5 years in a Cell & Gene Therapy (CGT) or Biologics leadership role 

• Deep understanding of global cGMP regulations (FDA, EMA, ICH) including phase-appropriate requirements for clinical vs. commercial products 

• Demonstrated record of authoring CTD sections for IND, BLA/MAA, and/or post-approval submissions 

• Expertise in analytical method validation, process development, tech transfer, and viral vectors (e.g. LVV) 

• Expertise in designing and executing product & process control and comparability strategies 

• Demonstrated ability to clearly articulate complex technical concepts to cross-functional, senior management, and regulatory audiences 

• Demonstrated success in a fast-paced, matrixed environment with a collaborative, problem-solving mindset, including an ability to influence diverse stakeholders and drive decision-making without direct authority 

The annual base pay for this position ranges from $167,595.20 - 251,392.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.