Manager, Quality Assurance Operations

Fate Therapeutics is seeking an experienced and motivated Manager, Quality Assurance Operations to support Fate’s internal and external cGMP manufacturing operations. The successful candidate must thrive in a fast-paced team environment, have excellent communication, planning, and organizational skills, and manage quality assurance activities to meet Fate’s priorities and timelines. The candidate must have experience of overseeing Quality Assurance functions in support of analytical testing relating to method development, validation, and in-process, release and stability testing for raw materials, drug substance and drug product. This position will assist in establishing and maintaining a quality management system to support GXP-compliant manufacturing operations and will be expected to effectively follow Fate’s SOPs and policies. This is a full-time position reporting to the Senior Manager, Quality Assurance and is located at our corporate headquarters in San Diego, California.
Responsibilities

• Manage, review, and track internal and external analytical data to support disposition of drug products, cell banks, and other materials required for drug product manufacturing
• Review and approve test data from internal and external sources in compliance with regulatory requirements and Fate SOPs
• Oversee proper execution of product stability testing including data trending and impact on product expiry
• QA oversight of lab/OOS investigations, deviations, and corrective and/or preventive actions, and ensure proper product impact assessment
• Provide QA oversight of internal QC laboratory and act as QA SME with external test laboratories
• Provide QA guidance in the development of product and material specifications
• Review and approve analytical method development, qualification, and validation protocols and reports in collaboration with assay development and QC teams
• Ensure proper training of applicable departments in accordance with Fate SOPs and applicable regulations
• Review and approve stability protocols and reports
• Review and approve research and development reports
• Revise, review, and approve analytical method SOPs in Fate’s established eDMS
• Support establishment of electronic LIMS system in collaboration with QC and IT
• 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 

Qualifications

• Bachelor’s or advanced degree in a relevant scientific area with a minimum of 5 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. Page 2 of 2
• 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.
• 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 

Working Conditions and Physical Requirements

• Occasional evening and weekend work may be required.
• May require occasional travel. 

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.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.