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. This role will support multiple clinical manufacturing facilities at AstraZeneca’s Santa Monica, CA and Tarzana, CA locations 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. Date Posted 27-May-2026 Closing Date 11-Jun-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.