Associate Director, Quality Assurance (Hospital Qualifications and Regional Operations Quality)

Location
Foster City
Salary
See job description.
Posted
August 02 2021
Ref
R0021183
Position Type
Full Time
Organization Type
Pharma


Associate Director, Quality Assurance (Hospital Qualifications and Regional Operations Quality)
Brazil - Sao Paulo

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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We are seeking a highly motivated individual to join us as Associate Director, Quality Assurance (Hospital Qualifications and Regional Operations Quality) in Brazil . 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; final product release and Responsible Pharmacist role. This position will be located in Brazil; reporting to Quality Assurance Leadership at Kite.

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.
  • Perform new site qualifications (including audits and trainings) and monitoring of authorized ACTS.
  • With Global Site Qualification 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 on the area of site qualification process and management.
  • Assess and approve any changes to the courier tracking and order intake systems to assure 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.
  • Support inspection readiness plans and interact with regulatory agencies during inspections on ATCS -related matters.
  • Work with Global Site Qualification, US, Canada, Australia and EU ATC qualification teams, as needed.
  • Recruit, manage and develop a team that improves and executes Kite's ATCS Qualification Program.
  • Collaborate with our Gilead affiliates in the routine management of the ACTS relationships.
  • Execute timely release of Cell Therapy products in Brazil and Responsible Pharmacist (Responsible Person) responsibilities that include applicable GMP and GDP (recalls, product complaints, returns and self-inspections).
  • 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 Brazil.
  • Perform other duties as assigned.


Requirements:
  • Bachelor's degree in Pharmacy or equivalent
  • Qualified Person (QP) currently registered in Brazil
  • Extensive relevant experience in medical, pharmaceutical or biologics quality systems' roles; apheresis/transplant/infusion centers, blood banks, nursing, or blood/human tissue experience preferred
  • 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.
  • Experience with product import lot disposition, deviation and change control management preferred.
  • Proficiency in English
  • Strong working knowledge of and ability to apply GMP in conformance to ANVISA and ROW standards
  • 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 40%, could include some weekend travel for arrival to/return from destinations, and up to 60% during launch preparation


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 based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Brazil---Sao-Paulo/Associate-Director--Quality-Assurance--Hospital-Qualifications-and-Regional-Operations-Quality-_R0021183-1





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