Director / Associate Director, Quality Assurance

Location
San Diego, CA, United States
Posted
Mar 25, 2021
Ref
468LR
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics is seeking an experienced and motivated Associate Director of Quality Assurance. This position will be responsible for supporting 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 independently manage priorities to meet Fate's objectives and timelines. The candidate must be proficient in the development and maintenance of quality management systems and will be expected to effectively follow and improve Fate's SOPs, policies, and compliance with cGXP regulations. This is a full-time position reporting to the Head of Quality Assurance and is located at our corporate headquarters in San Diego, California.

Responsibilities
• Manage and conduct QA review of internal and external production documentation, including batch records, analytical records, and any supporting documentation to ensure compliance with cGMP and Fate policies and procedures.
• Prepare and approve disposition documentation for drug products, starting materials, and raw materials.
• Lead and perform routine reviews of all cGMP documentation including laboratory notebooks, equipment logs and facility monitoring reports.
• Lead QA support of tech transfer to CMOs and qualification of manufacturing activities.
• Create and/or utilize various databases to track on-going QA activities including lot disposition status, compliance issues, and other Quality metrics.
• Proactively identify, investigate, and propose solutions to compliance issues and lead closure of deviations and completion of corrective and/or preventative actions in collaboration with other departments.
• Perform quality oversight of the GMP facilities and ensure training of personnel in compliance with Fate's requirements and industry standards.
• Perform day-to-day activities of Document Control including creation and/or revision, processing, routing, and releasing controlled documents using Fate's eDMS.
• Provide QA support during Fate manufacturing operations and act as QA Person-In-Plant at Contract Manufacturing Organizations.
• Review and approve development study protocols and reports and support Regulatory submissions to health authorities by performing data review and verification.
• Perform in internal and external Quality audits of FATE departments and contract organizations.
• Support QA and Fate Senior Management with various projects as needed.

Qualifications
• Minimum seven years of Quality Assurance related experience in a cGMP regulated manufacturing environment is required
• Bachelor's degree or higher in a relevant scientific area
• Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
• Knowledge and ability to sufficiently train others on regulatory compliance issues
• Strong interpersonal skills and ability to work with others in a positive and
collaborative manner
• Strong verbal and written communication skills
• Strong prioritization and organizational skills
• Knowledge of cGMP concepts and guidelines, as well as good documentation
practices
• Ability to utilize multiple word-processing and database applications
• Experience with an electronic document system is preferred
• Experience with contract manufacturing operations is a plus
Working Conditions and physical requirements
• Will require 10%-50% travel
• Occasional weekend and/or evening hours required
• Full-time onsite work at corporate headquarters in San Diego, CA
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. For consideration send cover letter and resume to: careers@fatetherapeutics.com and reference job code 468LR.

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). The Company's pipeline also includes ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease in patients with hematologic malignancies undergoing allogeneic stem cell transplant. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.