Senior Manager - Quality Assurance Kite

Melbourne, VIC
Permanent
Full-time

1 month ago

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 DescriptionAt Gilead, we’re committed to creating a healthier world for everyone – no matter the challenges ahead of us. For more than 30 years, we’ve pursued the impossible, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Through bold and transformative science, we’re driving innovation that has the potential to become the next generation of life-changing medicines. Our ambition is evident in our mission. Because the impossible is not impossible. It’s what’s next.The Position:We are seeking a highly experienced and motivated individual to join us as Associate Director or Senior Manager, Product and Distribution Quality in ANZ. You will work with Quality, Commercial, Regulatory, Supply Chain, and Medical Affair in supporting our efforts in this exciting area of cancer immunotherapy. This individual will work cross functionally 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, investigations related to product complaints, the cross-functional work for global labeling capabilities, the full set of capabilities associated to Responsible Person (RP) in ANZ and other APAC region as needed, and representing QA in ANZ regional Leadership teams as well as representing Kite with external partners and others.Key Responsibilities will include:

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.
With Global Site Qualification will determine strategy for maturing the ongoing program, sustainability and compliance to regulatory changes.
Collaborate with cross-functional departments to ensure timely implementation of quality processes.
Provide leadership and direction in the industry in the area of site qualification process and management.
Assess and approve any changes to the 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.
Assure business systems are developed, supported and maintained validated state for patient traceability.
Act as Quality contact, or delegate, for ATCS issues and discrepancies, and lead/manage the investigations to resolve the issues.
Interacts with the Kite T cell Facilities as needed for product release, issue resolving or other as applicable
Support inspection readiness plans and interact with regulatory agencies during inspections on ATCS-related matters.
Work with Global Site Qualification, America, EME and APAC regional leads , as needed.
Collaborate with our Gilead affiliates in the routine management of the ACTS relationships and in other areas as needed
Serve as Gilead RP per the local guidelines (TGA, HSA etc.). Act as back-up for RP in other APAC region as needed. Verify lot distribution confirmation for Kite cell therapy product and related activities in compliance with local regulations and internal SOPs and supervise quality/regulatory aspects of distribution in Australia and Singapore.
Provide quality oversight and execute responsibilities designated for the Responsible Person in country that includes the following QMS: distribution (under GDP), product complaints, recall, returns, self-inspection.
Provide oversight of deviation investigations which occur during the manufacturing, packaging and shipment of products and provide QA oversight and approval of Change Control records impacting Cell Therapy products in Australia, Singapore and other APAC region.
Maintain local Quality System to comply with local regulation.
Quality lead for Material Review Board for Cell Therapy Finished Products for Australia and Singapore
Perform other duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Knowledge, Experience and Skills Required:

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 is 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 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 40%, could include some weekend travel for arrival to/return from destinations

Gilead Core ValuesIntegrity (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)Being Here MattersAt Gilead we are committed, hardworking and passionate about improving the lives of the patients who use our products. Our values – integrity, inclusion, teamwork, accountability and excellence – are evident in everything we do. We are a close-knit team where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.We want all our employees to embrace and leverage each other’s talents and diverse perspectives, foster a sense of belonging, achieve their full career potential and contribute to the team’s success. This is demonstrated through our Silver Status in the Australian Workplace Equity Index.As an equal opportunity employer, Gilead Sciences is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.For Current Gilead Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.

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