Director, Supplier Quality Management - 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 Director, Supplier Quality Management. 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.
Responsibilities (include but are not limited to):
- Provide leadership for the management and improvement to the Supplier Quality Management Program
- Accountable for the GMP compliance of the Supplier Quality program elements: audits, QTAs, SCARs, management of supplier initiated changes.
- Lead, develop and manage the SQM team to assure compliance of the SQM elements. Manage cross-functionally within Kite and with the external suppliers and service providers to assure compliance and strong relationships.
- Direct the management and enhancement of supplier qualification and specification development processes that will use risk-based tools for qualification, classification and monitoring.
- Perform audits of and manage audit closure for suppliers of raw materials, components, contract labs, CMO sites, service providers and warehouses.
- Improve and execute the supplier QTA process (in collaboration with legal and supply chain) and assure a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed.
- Direct implementation and execution of supplier change management system for raw material/component suppliers, contract labs, CMOs and warehouses.
- Assure audit schedule and approved supplier list (Oracle Agile and EBS) are maintained.
- Provide direction to team when Quality contact for supplier issues and discrepancies, and lead/manage the investigations to resolve the issues as warranted for significant matters.
- Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
- Ability to travel up to 10%
- Perform other duties as assigned.
- Bachelor’s degree in biological sciences or related field with minimum of 10 years experience in a pharmaceutical or biologics supplier quality management role; biologics, vaccines or material science experience preferred.
- Previous experience managing and developing staff with a minimum of 8 years of experience.
- Experience auditing suppliers for raw materials, primary and secondary packaging components, contract labs, CMO sites, service providers and warehouses.
- Experience with direct FDA interaction (or other regulatory agencies) required
- ASQ Certified Quality Auditor preferred
- Experience in identifying, writing, evaluating and closing investigations.
- In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
- Willingness to think outside of the box and adapt best practices to this small, but growing environment
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- 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, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? 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.
No phone calls please and no agencies or recruiters.