Experienced Quality Professional Wanted

2 days ago

Melbourne, Victoria, Australia beBeeQuality Full time $150,000 - $200,000

This is an exciting opportunity to join our organization as a Senior Manager.

About the Job

We are seeking a highly experienced and motivated individual to lead a multi-market organization focused on implementing and ensuring the qualification and monitoring program for hospital apheresis centers and treatment sites that will provide treatment to patients with our commercial products.

The successful candidate will work cross-functionally to 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.

  • Establish and implement quality processes across the organization.
  • Determine strategy for maturing the ongoing program, sustainability and compliance to regulatory changes.
  • Collaborate with cross-functional departments to ensure timely implementation of quality initiatives.
  • Provide leadership and direction in the industry in the area of site qualification process and management.
Key Responsibilities:
  • Assess and approve any changes to 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.
  • Act as Quality contact, or delegate, for ATCS issues and discrepancies, and lead/manage the investigations to resolve the issues.
  • Interact with the Kite T cell Facilities as needed for product release, issue resolving or other as applicable.
About You

We are looking for a highly experienced and skilled professional who possesses a strong background in medical, pharmaceutical or biologics quality assurance' roles.

You will have a minimum of 7 years progressive experience in this field, with a Bachelor's degree in medical or biological sciences or related field; Master's or PhD degree preferred.

  • A strong understanding of GMP regulations and guidelines.
  • Experience auditing blood banks, plasma centers, apheresis centers, external suppliers and/or internal GMP systems.
  • Proficiency in English is required.
What We Offer

We offer a competitive compensation package, excellent benefits and opportunities for growth and development.

Our team values integrity, teamwork, excellence, accountability and inclusion, and we strive to create a collaborative and supportive work environment.

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