At Gilead, we are driven to create a healthier world for all people. With over 30 years of experience in tackling diseases like HIV, viral hepatitis, COVID-19, and cancer, our therapies aim to improve lives and ensure global access.
Every team member plays a vital role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we strive to achieve our bold ambitions.
We believe every employee deserves exceptional leadership. People Leaders are instrumental in shaping our culture and creating an inclusive environment where every employee feels valued, developed, and empowered to fulfill their aspirations.
The Role:
We are seeking an experienced and motivated individual to join our team as Associate Director or Senior Manager, Product and Distribution Quality in ANZ. This position will work closely with Quality, Commercial, Regulatory, Supply Chain, and Medical Affair teams to support our efforts in cancer immunotherapy.
Key Responsibilities include:
* Establishing, executing, and managing new and established apheresis centers and treatment centers sites qualification processes using risk-based tools for qualification, training, and monitoring.
* Determining strategies for maturing ongoing programs, sustainability, and compliance to regulatory changes with Global Site Qualification.
* Collaborating with cross-functional departments to ensure timely implementation of quality processes.
* Providing leadership and direction in site qualification process and management.
* Assessing and approving changes to courier tracking and order intake systems to maintain validated state.
* Leading Quality's collaboration efforts with Commercial in start-up and routine management of the ATCS relationship and Supply Chain to ensure compliance across the Kite product Journey and best customer experience.
* Implementing, assessing, and reporting on metrics monitoring per schedule and providing updates to approved ATC list.
* Ensuring business systems are developed, supported, and maintained in a validated state for patient traceability.
* Acting as Quality contact or delegate for ATCS issues and discrepancies, leading/managing investigations to resolve issues.
* Interacting with Kite T cell Facilities as needed for product release, issue resolving, or other applicable activities.
* Supporting inspection readiness plans and interacting with regulatory agencies during inspections on ATCS-related matters.
* Collaborating with Global Site Qualification, America, EME, and APAC regional leads as needed.
* Serving as Gilead RP per local guidelines (TGA, HSA, etc.). Acting as back-up for RP in other APAC region as needed. Verifying lot distribution confirmation for Kite cell therapy product and related activities in compliance with local regulations and internal SOPs and supervising quality/regulatory aspects of distribution in Australia and Singapore.
* Providing quality oversight and executing responsibilities designated for the Responsible Person in country including QMS: distribution (under GDP), product complaints, recall, returns, self-inspection.
* Providing oversight of deviation investigations which occur during manufacturing, packaging, and shipment of products and providing QA oversight and approval of Change Control records impacting Cell Therapy products in Australia, Singapore, and other APAC region.
* Maintaining local Quality System to comply with local regulation.
* Quality lead for Material Review Board for Cell Therapy Finished Products for Australia and Singapore
Required Skills and Qualifications:
To be successful in this role, you will need:
* 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 required.
* Strong working knowledge of and ability to apply GMP in conformance to ANZ.
* Experience responding to regulatory agency audits.
* Demonstrated ability to develop, coach, and mentor employees.
* Excellent interpersonal, verbal, and written communication skills 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.
Gilead Core Values:
We embody:
Integrity - always doing the right thing
Teamwork - collaborating in good faith
Excellence - working at a high level of commitment and capability
Accountability - taking personal responsibility
Inclusion - encouraging diversity