Manager, Quality Operations
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Job Description
Manager of Quality Operations for Kite ensuring quality in CAR-T cancer immunotherapy processes. Collaborating across teams to maintain and monitor treatment center qualifications and compliance.
Responsibilities:
- Assess and approve any changes to Apheresis Collection Module, 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 (Deviations, CAPA, Change control, etc.)
- Assist in the 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%
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 and Cell Therapy 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
- 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
Benefits:
- company-sponsored medical, dental, vision, and life insurance plans*
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
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