Manager, Quality Assurance Operations

Fate Therapeutics is seeking a highly motivated and experienced Manager, Quality Assurance Operations to support our cGMP site operations. The ideal candidate will thrive in a fast-paced environment and possess strong communication, planning, and organizational skills. This role is responsible for managing activities that drive the Company’s priorities and timelines. The successful candidate will have demonstrated experience overseeing Quality Assurance functions in support of manufacturing operations and/or analytical testing. This includes expertise in process and method development, validation, release, and stability testing for raw materials, drug substance, and drug product. This position will also play a key role in establishing and maintaining a robust Quality Management System to support GxP-compliant manufacturing operations. This is a full-time position reporting to the Associate Director, Quality Assurance and is located at our corporate headquarters in San Diego, California.

• Manage, review, and track production and analytical records to support disposition of raw/starting materials, intermediates, drug products, and other materials.
• Review and approve batch records and test data in compliance with regulatory requirements and Company standard operating procedures (SOPs).
• Oversee proper execution of GMP operations including material control, production, and testing activities.
• Quality Assurance (QA) oversight of nonconformances, including lab/OOS investigations, deviations, corrective and/or preventive actions, and ensure proper product impact assessment.
• Provide QA oversight of internal GxP operations and act as QA with external test laboratories or manufacturing organizations.
• Provide QA guidance in the development of product and material quality attributes.
• Review and approve analytical method/process qualification, verification and validation protocols and reports in collaboration with subject matter experts.
• Ensure proper training of applicable departments in accordance with Fate SOPs and applicable regulations.
• Review and approve protocols and reports to support stability and other GMP studies.
• Review and approve research reports.
• Review and approve batch records and analytical method SOPs in Fate’s established eDMS.
• Contribute to the revision, update, and approval of SOP’s.
• Manage, train, and mentor team in support of data review and analysis and internal investigations.
• Prepare teams responsible for data integrity and collection for inspection readiness.
• Support QA Management with various projects as needed.

• Bachelor’s or advanced degree in a relevant scientific area with a minimum of 6 years of Quality Assurance experience in a cGMP regulated manufacturing environment.
• Experience with assay development, validation and/or quality control for viral or biological drug products is required.
• Strong understanding and knowledge of GXP, ISO, and ICH concepts and guidelines, and implementation of GXP in a Phase appropriate manner in conformance to US & EU standards.
• Strong understanding in material disposition, batch record review, NCMR review, QA observation for manufacturing activities, and material/product disposition requirements.
• Must have a strong understanding of OOS investigation procedures, deviations, CAPA’s and change controls.
• Demonstrated ability to work independently, prioritize, and complete activities in a timely manner; self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Strong verbal and written communication skills and ability to work cross-functionally in a positive and collaborative manner.
• Experience / knowledge in cell-based assays is highly preferred.

• May require occasional travel.
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. 

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $120,000 - $140,000.

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

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About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.