This position supports a consistent quality oversight / approach throughout the Development Process and the Commercial Product Lifecycle for assigned Atara products. The Product Quality Leader acquires and applies product-quality knowledge and acts as the quality expert for assigned products or intermediates throughout the product lifecycle working closely with the product teams and partners.
Reports to Director Product Quality Leadership
Location Thousand Oaks, CA OR Remote
Travel Up to 20%
Primary Responsibilities: Serves as the quality expert for assigned ATARA programs and is responsible for making strategic quality decisions throughout the product lifecycle. Provides a proactive front-end approach to product quality. Provides direction and alignment across different functions and influences both strategic and tactical Quality input to develop product quality strategies and life cycle management decisions for both clinical and commercial products in alignment with overall product strategies and is accountable for decisions on product quality. Actively monitors product metrics and signals (e.g. cpk /stability, etc.) and initiates / supports improvement projects to enhance performance and /or mitigate quality or compliance risks across development portfolio. Works in partnership with Process Science to ensure there are established overall Product Quality Profiles and implementation of QbD principles. In collaboration with operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations. Supports and enables strategic management of Quality Risk Management (QRM) for Atara products. Participates in and supports complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities. Quality approver of key strategic product documents (e.g. Specifications, Stability Plans, Process descriptions, QbD documents, Process Development plans). Ensures holistic quality reviews are performed and standards established for regulatory filings, inspections and compliance audits as required. Represents Quality in CMC Team, Program Team, and business partner meetings to provide strategic direction and leadership to product development, registration, and approvals. Manages the APR / PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions arising are managed to conclusion. Interfaces with Regulatory Affairs to author, review, and approve filings, and represents Quality in product related agency meetings.
Qualifications Bachelor's Degree in Virology, Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology 10+ years pharmaceutical experience, preferred experience in cell therapy or biologics product development and licensure. Demonstrated expert knowledge of relevant global regulations and guidance. Experience in cell-based process development and validation. Experience in product licensure. Knowledge of ATMP guidance. Ability to think strategically and to influence others. Excellent verbal and written communication skills; good interpersonal skills. Strong scientific and global cGMP compliance expertise to ensure robust analysis of complex data to recommend and/or make risk-based Quality decisions in biopharmaceutical product life cycle management. Collaborate cross-functionally, develop strong relationships with partners both internally and externally. Confident, independent, self-starter, proactive, and results-oriented with high performance standards. Exhibits highest integrity and committed to ethics and compliance standards. Strong ability to prioritize and operate with a sense of urgency. Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)