Sr Manager, Quality Assurance

Description

• Establish, execute and manage the new and established apheresis centers and treatment centers sites (ACTS) qualification process that will use risk-based tools for qualification, training and monitoring.
• With Global Site Qualification will determine strategy for maturing the ongoing program, sustainability and compliance to regulatory changes.
• Collaborate with cross-functional departments to ensure timely implementation of quality processes.
• Provide leadership and direction in the industry in the area of site qualification process and management.
• Assess and approve any changes to the courier tracking and order intake systems to assure the validated state of the systems is maintained.
• Lead Quality’s collaboration efforts with Commercial in the start-up and routine management of the ATCS relationship and Supply Chain to ensure compliance across the Kite product Journey and best customer experience
• Implement, assess and report on metrics monitoring per schedule and provide updates to approved ATC list.
• Assure business systems are developed, supported and maintained validated state for patient traceability.
• Act as Quality contact, or delegate, for ATCS issues and discrepancies, and lead/manage the investigations to resolve the issues.
• Interacts with the Kite T cell Facilities as needed for product release, issue resolving or other as applicable
• Support inspection readiness plans and interact with regulatory agencies during inspections on ATCS-related matters.
• Work with Global Site Qualification, America, EME and APAC regional leads , as needed.
• Collaborate with our Gilead affiliates in the routine management of the ACTS relationships and in other areas as needed
• Serve as Gilead RP per the local guidelines (KFDA etc.). Act as back-up for RP in other APAC region as needed. Verify lot distribution confirmation for Kite cell therapy product and related activities in compliance with local regulations and internal SOPs and supervise quality/regulatory aspects of distribution in Australia and Singapore.
• Provide quality oversight and execute responsibilities designated for the Responsible Person in country that includes the following QMS: distribution (under GDP), product complaints, recall, returns, self-inspection.
• Provide oversight of deviation investigations which occur during the manufacturing, packaging and shipment of products and provide QA oversight and approval of Change Control records impacting Cell Therapy products in South Korea and other APAC region.
• Maintain local Quality System to comply with local regulation.
• Quality lead for Material Review Board for Cell Therapy Finished Products for South Korea
• Perform other duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Qualifications

• Bachelor’s degree in medical or biological sciences or related field; Master’s or PhD degree preferred
• Minimum of 7 years progressive experience in medical, pharmaceutical or biologics quality assurance’ roles; preferred cell therapy.
• Experience in areas such as Clinical Research, Medical Liaison, Cell Therapy and/or Apheresis and Cell Therapy Medical Centers preferred.
• Experience auditing blood banks, plasma centers, apheresis centers, external suppliers and/or internal GMP systems.
• Experience working in multi-national companies with management responsibilities of staff located in multiple regions/countries.
• Proficiency in English and Korean are required
• Strong working knowledge of and ability to apply GMP in conformance to South Korea (KFDA).
• Experience responding to regulatory agency audits.
• Demonstrated ability to develop, coach, and mentor employees
• 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.
• Ability to travel up to 40%, could include some weekend travel for arrival to/return from destinations