This website uses cookies to ensure you get the best experience. Learn more
Gilead

Associate Director, Quality Assurance

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

We are seeking a highly motivated individual to join us as Associate Director, Quality Assurance for our Melbourne office, responsible for the Hospital Site Qualifications and performing the duties of the Authorised Person (AP) for Australia.  This is in support of Kite’s Cell Therapy products which are imported and distributed in Australia. This position will report into Global Quality at our Kite corporate office in Santa Monica, California.

Responsibilities:

  • Responsible for the Hospital Site Qualifications in Australia:
  • Establish, execute and manage the apheresis and treatment center (ATC) qualification process
  • With Global Site Qualification, determine the strategy for sustaining and maturing the program to remain complaint with regulatory requirements.
  • Collaborate with the Commercial Team during product launch and on-going management of the ATC relationship.
  • Perform Site Qualification audits, and ensure on-going adherence to qualification requirements.
  • Implement, evaluate, and report on metrics per schedule, and provide updates to approve ATC List.
  • Assure that business systems are developed and maintained for patient traceability.
  • Quality point of contact for ATC issues and ensure resolution of issues as needed.
  • Participate in the Global Site Qualification Team.
  • Responsible for the implementation, execution, and maturation of Quality Systems for cell therapy product(s) in order to be compliant with Australia CGMP requirements:
  • Perform Gap Assessment to ensure that Kite QMS meets the Australia CGMP requirements.
  • Create processes and procedures, to include release of product, product complaints, and recalls.
  • Review batch-related documentation and release Final Product for distribution.
  • Oversee deviation investigations related to manufacturing, packaging, and shipment.
  • Oversee Change Controls associated with Australia product(s).
  • Participate in the Annual Product Review.
  • Participates in TGA (Therapeutic Goods Administration) inspection and communication, as needed.
  • Participate in the Global QA Operations Team.
  • Recruit, manage, and develop team to support Site Qualifications and Quality Systems.
  • Ability to travel up to 50% especially during launch preparations.

Requirements:

  • Bachelor’s degree in the biological sciences or related field
  • Minimum of 10 years of relevant experience in Biopharmaceutical or Biologics.  Cell Therapy experience preferred.
  • Deep knowledge and experience in Quality Assurance in a highly regulated manufacturing environment.
  • Prior people management experience.
  • Broad experience across areas like Quality Assurance and/or Quality Systems, and understanding of parenteral and aseptic operations is beneficial.
  • In-depth understanding and application of CGMP principles, concepts, practices and standards in Australia and internationally.
  • Comfortable interacting with regulatory agencies as needed.
  • Experienced Auditor with demonstrated acumen in resolving challenging audit situations.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.


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.
 

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Apply Now

Share this