Senior Manager / Assoc Director, Quality Assurance

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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 or Sr. Manager, Quality Assurance (Regional Operations Quality) in Australia. 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 Australia your responsibilities will include Product Complaint investigations, self-inspections, training and others. This position will be located in Australia; reporting to APAC Quality Assurance Lead.

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.

Collaborate with golobal team to ensure proper management of quality processes to comply with local regulatory requirements.

Provide leadership and direction for quality related topic to the local team.

Assess and approve Change Control related to processes and systems.

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 quality metrics and ACTS monitoring.

Act as Quality contact, or delegate, for quality matters and ATCS issues, and lead/manage the investigations to resolve the issues.

Lead/Support inspection readiness plans and interact with regulatory agencies during inspections.

Work with Global Site Qualification, US, EU, and APAC ATC qualification teams, as needed.

Collaborate with our Gilead affiliates in the routine management of the ACTS relationships.

Serve as Gilead RP for Kite cell therapy products per the local guidelines (TGA etc.) and act as back-up for RP in other APAC region as needed.

Verify and manage lot distribution confirmation for Kite cell therapy product and related activities in compliance with local regulations and internal SOPs.

Provide quality oversight and execute responsibilities designated for the Responsible Person in country that includes the following QMS.

Maintain local Quality System to comply with local regulation.

Quality lead for Material Review Board for Kite cell therapy products for Australia.

Perform other duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as neede

Requirements:

Progressive experience in medical, pharmaceutical or biologics quality systems’ roles; apheresis/transplant/infusion centers, blood banks, nursing, or blood/human tissue experience preferred.

7+ years of relevant experience in a GMP environment related field and a Bachelor’s degree in science or related fields.

5+ years of relevant experience and a MS.

Minimum of 3-5 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.

Strong working knowledge of and ability to apply GMP/GDP/GQP in conformance to Australia (TGA).

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 written communication skills are 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 25%, may include some weekend travel for arrival to/return from destinations.

Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.