Allogene is seeking an Associate Director/ Director of External Quality Assurance to lead the Quality Assurance function for Contract Manufacturing Operations (CMO) Oversight. This position will require active engagement and strategic vision for the QA role in the company. The position will be responsible for providing direction and decision regard to quality oversight of starting material (SM), drug substance (DS) and drug product (DP) and labeling and packaging operations at the CMO. Role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships including both internal and external stakeholders. Excellent communication skills and demonstrated ability to work well with others will be essential.
Responsibilities include, but are not limited to:
- Provides Quality functional leadership including hiring and managing, high performing quality assurance staff designed to meet the technical and compliance requirements of a growing company
- Provide QA support for the manufacturing and disposition of GMP starting materials, Drug Substance, Drug Product, and packaged and labeled products. Responsible for disposition of GMP products utilizing trained and qualified QA staff. In addition, collaborate with Manufacturing, Supply Chain and CMC Program Management to assure on time delivery of approved products.
- Work directly with operating entities (internal and CMOs) to ensure that products (i.e., SM, DS, DP, and packaged and labeled product) meet all required quality standards and specifications.
- Influence other functional departments to ensure that CMOs achieve and maintain the appropriate levels of GMP compliance and provide quality services to Allogene. In addition, work with CMOs to ensure CMOs’ cGMP processes and procedures provide continuous evaluations and improvements to their quality systems.
- Build strong interdependent relationship with the CMO Project Management Counterparts and Quality Assurance and Quality Control teams in order to assess the as is state & risks for action-oriented improvement plans.
- Provide QA guidance and support for supplier qualification, technology transfer, scale-up, validation and other GMP activities associated with products manufactured by CMOs.
- Facilitate resolution of quality issues with internal and external parties in a timely manner. Coordinate communications with CMOs and internal technical product teams for quality issues.
- Responsible for executing Quality Assurance (QA) programs and activities; this includes assisting with training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, reports and manufacturing records.
- Represent the Quality function in product development (CMC) teams, engaging all quality stakeholders to ensure product deliverables are met through the product lifecycle.
- Review and approve CMC sections of regulatory filings as needed.