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Featured Employers
Director / Sr. Director, Quality Assurance
Company: Kezar Life Sciences
Location: South San Francisco, CA
Employment Type: Full Time
Date Posted: 02/22/2021
Expire Date: 04/22/2021
Job Categories: Biotechnology and Pharmaceutical
Job Description
Director / Sr. Director, Quality Assurance
Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Director/Senior Director of Quality Assurance. The Director/Senior Director will report to the Vice President of Legal Affairs and will be responsible for developing and growing the Quality Assurance department while providing leadership, strategy, and for ensuring compliance with all relevant health authority regulations and guidelines as they pertain to GxP. The ideal candidate must thrive in a fast paced team environment, have excellent communication, planning, and organizational skills. Candidate must have experience and a proven track record of establishing and maintaining a Quality department and Quality Management System (QMS) to support multiple molecules and pipelines of a growing biotechnology company.

Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar’s lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar’s first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is entering Phase 1 clinical trials in several oncology indications.

Requirements
• Lead strategic QA planning and risk assessment
• Evaluate events, incidents, queries, and complaints; initiate and perform investigations as necessary
• Manage corrective and preventive action (CAPA) plans
• Provide GxP QA oversight of all contract service providers (CSP) including clinical research organizations, central labs, investigator sites, drug substance
and drug product manufacturers, distribution centers, and other key CSPs
• Participate in the evaluation, selection, and qualification of CSPs
• Establish and maintain vendor Quality Agreements
• Write, revise, and periodically review SOPs to further develop the QMS and provide oversight of the quality of vendor services and products
• Develop and facilitate GxP training for functional areas and personnel involved; ensure proper training company wide to meet GxP and ICH requirements
• Plan and manage GxP compliance audits
• Perform manufacturing batch record review and release
• Review and/or approve deviations, out of specification results (OOSs), out of trend results (OOTs), out of expectation results (OOEs), CAPAs, and
change control
• Support regulatory inspections; internal and external
• Manage one or more direct reports

Experience
• Bachelor’s degree in a scientific discipline, 8 12 years QA experience in the pharmaceutical/bio pharm industry
• Experience performing GxP audits
• Comfortable in a fast paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Strong understanding of GMP/GCP/GLP global regulations and guidance
• Must have excellent verbal and written skills
• Strong organizational skills
• Excellent interpersonal skills with ability to effectively interact with different functional groups at all levels of the organization
• Willing to travel up to 25%

Contact Information
Company Name: Kezar Life Sciences
Website: https://apply.workable.com/kezar/j/...
Company Description:
Founded in 2015 and based in South San Francisco, Kezar (pronounced “keys are”) Life Sciences is combining courage, conviction and cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders – with the hope of helping people overcome their disease and live a better life. We are pioneering first-in-class, small molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. We are translating our innovative research in protein degradation (via immunoproteasome inhibition) and protein secretion (via the Sec61 translocon) to have a significant clinical impact in the most difficult-to-treat diseases.
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