Senior Specialist, Supplier Quality Management
Quality | Santa Monica, CA | Full Time
Kite Pharma, Inc., is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. For more information on Kite, please visit www.kitepharma.com.
- Assist in management and enhancement of supplier qualification process that will use risk-based tools for classification, qualification and monitoring.
- Perform audits of and manage audit closure for suppliers: contract labs, CMO sites, service providers, specialty couriers and 3PLs.
- Develop and review supplier QTAs (in collaboration with Legal and Supply Chain) and establish a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed.
- Collaborate with spec development team to execute specification development process to create/change GMP part numbers, specifications and associated Item Master in Oracle EBS for testing material specifications (TMS).
- Assist in the management and execution of supplier change management system for contract labs, CMOs and GMP service providers.
- Assist in maintaining the audit schedule and approved supplier list (Oracle Agile and EBS) for assigned suppliers.
- Act as Quality contact for supplier issues and discrepancies (SCARs), and lead/manage the investigations to resolve the issues.
- Participate in selection and qualification of new suppliers.
- Perform metrics monitoring and refine metrics as needed.
- Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
- Ability to travel up to 25%
- Perform other duties as assigned.
- Bachelor’s degree in biological sciences or Materials Science with minimum of 5 years experience in a pharmaceutical or biologics supplier quality management role; biologics or vaccines experience preferred
- Experience auditing suppliers for raw materials, primary and secondary packaging components, contract labs, CMO sites, service providers and warehouses.
- QA Operations experience, a plus (eg, product disposition, deviations, change control, material review board, process validation)
- ASQ Certified Quality Auditor preferred
- Experience in identifying, writing, evaluating and closing investigations.
- Working knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Kite Pharma, is headquartered in Santa Monica, CA. To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.