Director / Sr. Director, Quality Assurance
Kezar Life Sciences, United States
Job Description
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 fastpaced 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 companywide 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, 812 years QA experience in the pharmaceutical/bio pharm industry
- Experience performing GxP audits
- Comfortable in a fastpaced 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%