Director Product Quality Leader

AstraZeneca•Rockville, MD

About The Position

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 .

Requirements

Bachelor’s or Advanced degree (MS/PhD preferred) in Life Sciences or Engineering (e.g., Biology, Biochemistry, Chemical Engineering)
10+ years in the biotech nology or biopharmaceutical industry, with at least 3 - 5 years in a Cell & Gene Therapy (CGT) or B iologics 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 transfe r, and viral vectors ( e.g. LVV)
E xpertise 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 a bility to influence diverse stakeholders and drive decision-making without direct authority

Responsibilities

Serve as the Quality representative on the CMC T eam and lea d 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.
D evelop 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 d evelop 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