Assoc Director, QA Site Qualification Lead

2 weeks ago

Singapore Gilead Sciences Full time

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Job Description:


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 currently adding additional talent as it focuses on developing the Cell Therapy program in Singapore in support of providing maximum access to patients with unmet needs.

Position Summary


We are seeking a highly motivated individual to join us as Associate Director, Quality Assurance (Regional Operations Quality) in Singapore.

You will work with the Quality and Commercial teams in supporting our efforts in this exciting new area of cancer immunotherapy.

This individual will work cross functionally to implement and execute a qualification and monitoring program for hospital apheresis centers and treatment sites that will provide treatment to patients with our commercial products.

Your responsibilities will include overseeing and executing the qualification requirements, auditing, training, monitoring and managing changes. In addition as the Responsible Person in Singapore your responsibilities will include Product Complaint investigations, self-inspections, training and others. This position will be located in Singapore; reporting to Quality Assurance Leadership at Kite.

Responsibilities (include but are not limited to):

  • Establish, execute and manage the apheresis centers and treatment centers sites (ACTS) qualification process that will use risk-based tools for qualification, training and monitoring.
  • Perform new site qualifications (including audits and trainings) and monitoring of authorized ACTS.
  • With Global Site Qualification 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 on the area of site qualification process and management.
  • Assess and approve any changes to the courier tracking and order intake systems to assure 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.
  • Support inspection readiness plans and interact with regulatory agencies during inspections on ATCS -related matters.
  • Work with Global Site Qualification, US, Canada, Australia and EU ATC qualification teams, as needed.
  • Recruit, manage and develop a team that improves and executes Kite's ATCS Qualification Program.
  • Collaborate with our Gilead affiliates in the routine management of the ACTS relationships
  • Provide quality oversight and execute responsibilities designated for the Responsible Person in country that includes the following

QMS:
distribution, 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 Singapore- Perform other duties as assigned

Requirements:

  • Minimum of 5 years progressive experience in medical, pharmaceutical or biologics quality systems' roles; apheresis/transplant/infusion centers, blood banks, nursing, or blood/human tissue experience preferred
  • Pharmacist background in Singapore preferred
  • Minimum of 35 years of management/leadership experience
  • Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
  • Experience auditing blood banks, plasma centers, apheresis centers, external suppliers and/or internal GMP systems.
  • Proficiency in English
  • Previous experience presenting and responding to regulatory agency audits.
  • Proficient in MS Word, Excel, and Power Point
  • Demonstrated ability to develop, coach, and mentor employees
  • Excellent interpersonal, verbal and writ

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