Manager, Quality Assurance – Western U.S. (West of the Mississippi) & Florida
Gilead Sciences
Summary
Kite is seeking a highly motivated, self-driven individual to join the North America Regional Quality Operations team as Manager, Quality Operations in the exciting new area of CAR-T cancer immunotherapy. You will work cross functionally to assist with the qualification and monitoring program for apheresis collection and treatment centers that supports Kite's rapid expansion of our commercially marketed cell therapy products.
Job description
Job Responsibilities
- Assess and approve any changes to Kite Konnect, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained.
- Assist in the management of an apheresis and treatment center (ATC) qualification process using risk-based tools for qualification, training, monitoring and disqualification.
- Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.
- Perform a variety of audits, qualify and monitor compliance to qualification requirements.
- Maintain the monitoring schedule and approved ATC list.
- Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.
- Support and/or own quality records (ATC, Deviations, CAPA, Change control, etc.)
- Assist in development, implementation and management of ATC management system (GVault).
- Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.
- Ability to travel up to 40%.
Basic Qualifications
- Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD.
Preferred Qualifications
- Bachelor's degree in biological sciences, nursing, medical technologist or related field.
- 8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems' roles.
- Minimum 3-5 years quality assurance experience preferred.
- Experience managing external suppliers, blood banks, and plasma centers.
- Medical center or pharmaceutical auditing experience preferred.
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis, Cell Therapy Lab, and Medical Centers preferred.
- Previous experience in deviation management, development of corrective preventive/actions and change control, preferred.
- ASQ Certified Quality Auditor preferred.
- Strong working knowledge of and the ability to apply GMP and FACT/AABB standards.
- Previous experience presenting and responding to regulatory agency or certification audits, preferred.
- 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.
- Must be able to work independently, can multi-task and prioritize job responsibilities.
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
To be considered, candidates must currently reside in the Western U.S. (west of the Mississippi) or Florida at the time of application.
Requirements
- Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD
- Bachelor's degree in biological sciences, nursing, medical technologist or related field
- 8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems' roles
- Minimum 3-5 years quality assurance experience preferred
- Experience managing external suppliers, blood banks, and plasma centers
- Medical center or pharmaceutical auditing experience preferred
- Experience in areas such as Clinical Research, Medical Liaison, Apheresis, Cell Therapy Lab, and Medical Centers preferred
- Previous experience in deviation management, development of corrective preventive/actions and change control, preferred
- ASQ Certified Quality Auditor preferred
- Strong working knowledge of and the ability to apply GMP and FACT/AABB standards
- Previous experience presenting and responding to regulatory agency or certification audits, preferred
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills
- Must be able to work independently, can multi-task and prioritize job responsibilities
- Self-motivated, detail-oriented
- Ability to travel up to 40%
- Must currently reside in the Western U.S. (west of the Mississippi) or Florida
Benefits
- Medical, Dental & Vision
- Life Insurance
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.