Site Qualification Lead Saudi
UAE - Dubai
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
JOB DESCRIPTION TEMPLATE:
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 Saudi Arabia in support of providing maximum access to patients with unmet needs.
We are seeking a highly motivated individual to join us as Associate Director, Quality Assurance (Hospital Qualifications and Regional Operations Quality) in Saudi Arabia. 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 to responsibilities as the qualified person for distribution activity in country. This position will be located in Dubai at Gilead Affiliate; 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 responsibilities designated for quality for distribution activity to ensure the quality system is implemented and maintained (including 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 Saudi Arabia
- Perform other duties as assigned
- Bachelor's degree in Nursing, medical technology, biological sciences or related field; Master's degree preferred
- Minimum of 10 years progressive experience in medical, pharmaceutical or biologics quality systems' roles; apheresis/transplant/infusion centers, blood banks, nursing, or blood/human tissue experience preferred
- 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 and GSDP in conformance to Saudi Food and Drug Authority 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 Pharma, an equal opportunity employer. Kite Pharma is headquartered in Santa Monica, CA.
Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com
Sign up to follow @Kite Pharma on Twitter at www.twitter.com/kitepharma
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.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws including nationalization and residency restrictions and requirements). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/UAE---Dubai/Site-Qualification-Lead-Saudi_R0021181-2
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