Senior Manager, Quality Assurance
Quality | Newark, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a highly motivated individual for the role of Senior Manager of Quality Assurance to oversee the compliance, quality management systems and disposition of GMP products manufactured at Newark Facility. Responsibilities include review of executed batch records, approval of investigations, change control, CAPAs, managing internal audits and inspection management. Must be able to work independently and professionally in the execution of production. Must be able to manage responsibilities in a fast-paced environment, meeting production objectives, while ensuring quality requirements are met. This position is based in Newark, CA and is required to be on-site in accordance with Allogene’s Return Transition Plan.
Responsibilities include, but are not limited to:
- Write Quality procedures, policies, risk assessments, and training materials
- Support manufacturing on the floor, as required.
- Act as Newark process owner for Quality Management Systems (e.g., deviation, change control, CAPAs, document control)
- Create and manage the Newark inspection management program including inspection readiness and compliance assurance
- Manage the Newark internal audit program
- Coordinate with Supplier Quality to ensure suppliers are approved for materials used at the Newark facility
- Review batch-related documentation, and ensure proper resolution of quality issues prior to batch disposition
- Perform product dispositions for the Newark facility (may require initial development of the product disposition process in coordination with External Quality)
- Ensure all product-related deviations are initiated, investigated and properly addressed to assure product quality
- Authorize product shipments including release of material to clinical trial locations
- Coordinate Quality Review Board meeting covering QMS record reviews, material issues and other quality-related events
- Develop metrics for Newark quality processes
- Hire, Train, manage, coach and mentor staff as needed
- Other duties as assigned
Requirements & Experience:
- Bachelor’s degree in related science or engineering field with at least 5 years of experience in GMP regulated biopharmaceutical manufacturing with preference for experience with gene and cell therapy products
- Knowledge of quality systems and regulatory requirements including relevant US and EU guidelines
- At least 2 years of people management experience desired
- Direct experience with batch review and release; viral vector and or cell therapy product experience is preferred
- Advanced computer skills with MS Office applications Word, Excel, PowerPoint, as well as Adobe Acrobat
- Experience using SAP for disposition activities preferred
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably
- established timelines
- Ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.