Leader of Quality Assurance and Compliance

7 days ago

Melbourne, Victoria, Australia beBeeManager Full time $120,000 - $180,000
Senior Manager Job Description

We are seeking a highly experienced and motivated individual to join us as Senior Manager, Product and Distribution Quality. The successful candidate will work with our cross-functional teams to ensure the qualification and monitoring of hospital apheresis centers and treatment sites that provide treatment to patients with our commercial products.

The role involves establishing, executing, and managing the new and established apheresis centers and treatment center sites (ACTS) qualification process using risk-based tools for qualification, training, and monitoring. The candidate will also collaborate with global site qualification to determine strategy for maturing the ongoing program, sustainability, and compliance to regulatory changes.

Key responsibilities include:

  • Establishing and executing quality processes to ensure compliance across the Kite product Journey and best customer experience.
  • Providing leadership and direction in the industry in the area of site qualification process and management.
  • Assessing and approving changes to courier tracking and order intake systems to assure the validated state of the systems is maintained.
  • Implementing metrics monitoring per schedule and providing updates to approved ATC list.

Requirements:

The ideal candidate will have a Bachelor's degree in medical or biological sciences or related field; Master's or PhD degree preferred. A minimum of 7 years progressive experience in medical, pharmaceutical, or biologics quality assurance roles; preferred cell therapy. Experience auditing blood banks, plasma centers, apheresis centers, external suppliers, and/or internal GMP systems is essential.

The candidate must also have experience working in multinational companies with management responsibilities of staff located in multiple regions/countries. Proficiency in English is required, and strong working knowledge of and ability to apply GMP in conformance to ANZ.

Benefits:

We offer a competitive salary and benefits package, including opportunities for professional growth and development. Our company values integrity, inclusion, teamwork, accountability, and excellence, and we strive to create a diverse and inclusive workplace culture.

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