Senior Manager, Supplier Quality Management (Raw Materials) - United States
Kite is a biopharmaceutical company 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
We are seeking a highly motivated individual to join us as a Senior Manager, Quality Assurance. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This individual will work cross functionally to execute and improve the Supplier Quality Management (SQM) program that supports Kite’s rapid expansion to commercial manufacturing and first marketed product. Your responsibilities will include auditing, establishing and updating QTA’s, managing SCARs and coordinating assessment and implementation of supplier changes for raw material and component suppliers. This role will be a hands-on resource reporting to the Director, Quality Assurance (SQM-Materials).
Responsibilities (include but are not limited to):
- 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: raw materials and component suppliers.
- 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 raw materials and components.
- Assist in the management and execution of supplier change management system for raw materials and components.
- 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 8 years experience in a pharmaceutical or biologics supplier quality management role; biologics or vaccines experience preferred.
- Experience auditing suppliers for raw materials, sterile components, primary and secondary packaging components and sterilization facilities.
- 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.