Senior Manager, External Quality
Quality | South San Francisco, 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 Quality Assurance Senior Manager to oversee Contract Manufacturing Operation and the disposition of GMP products, including review of executed batch records, approval of investigations, change controls and other associated quality documentation. Must be able to work independently and professionally in the execution of Allogene’s supply chain responsibilities. Must be able to manage responsibilities in a fast-paced environment, meeting production objectives, while ensuring quality requirements are met. Will be able to design and develop core company QA policies and procedures with other quality leadership team members.
Responsibilities include, but are not limited to:
- Serve as Quality Contact for all quality and compliance events at Contract Manufacturing Partners
- Partner with Allogene operation site lead on issues, improvement, site performance and overall relationship management
- Negotiate and own quality agreements
- Perform QA person in plant activities such as review/ approve master batch records, specifications, shipping requests, deviations, change controls, corrective and preventative actions.
- Ensure all product-related deviations are initiated, investigated and properly addressed to assure product quality
- Identify and mitigate risk at the supplier and/ or escalate to management
- Drive audit commitment to completion
- Work with CMOs to insure timely receipt and resolution of batch documentation for GMP materials
- Support batch disposition by reviewing executed batch-related documentation, and ensure proper resolution of quality issues prior to batch disposition
- Ensure batch production files are organized and maintained
- Maintain metrics related to batch record review and product disposition in support of continuous improvement
- Other duties as assigned
Requirements & Experience:
- Bachelor’s degree in related science or engineering field with at least 7 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
- Direct experience with batch review and release of viral vector and or cell therapy product lots is preferred
- Works on multiple assignments in collaboration with internal and external customers
- Advanced computer skills with MS Office Suite, as well as Adobe Acrobat
- 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.