Associate Manager / Senior Quality Systems Administrator

Location
San Diego, CA, United States
Posted
Jun 30, 2020
Ref
367MW
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate's Quality Assurance (QA) group is seeking a motivated and talented individual to support development, implementation, and management of electronic quality systems. The successful candidate will assure adherence to standard operating procedures, GXP guidelines, and applicable regulations. The ideal candidate will have experience working in a cGMP environment and have hands-on experience in eDMS, eQMS, LMS, etc. Candidates must thrive in a fast-paced team environment and must have excellent attention to detail, communication, organizational abilities, and independent problem-solving skills. This is a full-time position reporting to the Associate Director, Quality Assurance, and is located at our company's headquarters in San Diego, California.

Responsibilities:
• Day to day management of the company's electronic systems related to quality, including, but not limited to: o Sourcing, researching, and presenting options for LMS, eQMS, and any other

electronic system to leadership to gain approval o Validation and implementation of electronic systems, including eQMS and LMS o Training end users and providing ongoing support to systems o System administrator for all electronic systems o Troubleshooting and maintenance for systems, including managing software

updates, change control, etc. o Assist with the daily management of the eDMS (Veeva Vault QualityDocs)
• Coordinate with IT to support, administer, and oversee other electronic systems such as ERP, LIMS, BMS, etc.
• Write, revise, and review documents relating to Quality Systems
• Proactively maintain an understanding of regulations and best practices for a robust Quality Management System e.g. FDA, USP, ICH, etc.
• Provide administrative support and assist with timeline tracking and QA metrics
• Perform other Quality related duties as assigned

Qualifications
• Bachelor's or associate degree in a relevant scientific discipline and a minimum of 5 years of relevant quality systems experience
• Prior hands on experience with QA or QE in the biotechnology or pharmaceutical industry that includes work on early stage products
• Prior hands on experience with system administration of electronic quality management systems, with a preference for Veeva Vault
• Prior hands on experience with LIMS, BMS, and ERP preferred
• Excellent organizational skills with a professional demeanor and the ability to work well in a team environment with cross-functional team members
• Experience preparing and reviewing cGMP documentation
• Working knowledge of 21 CFR Part 11, 211 and 210, FDA/ICH guidelines, and industry/technology standard practices including GMP, GCP, and GTP
• Excellent writing skills and proficiency with MS Office applications, particularly Word and Excel
• Strong attention to detail and communication skills
• Able to work independently and prioritize tasks in a fast paced and dynamic environment

Working Conditions and Physical Requirements
• May require occasional evening and weekend work.
• Full-time onsite work at company's headquarters in San Diego.
• Frequently required to work on a computer up to 8 hours a day.
• Occasionally required to stoop, kneel, and lift up to 50 pounds. 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 curriculum vitae to: careers@fatetherapeutics.com and reference Job Code 367MW.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. 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 product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include 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, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.