Senior Manager, Quality Assurance

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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.
 

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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
 

Senior Manager - Quality Assurance

We are seeking a highly motivated individual to join us as (Sr.) Manager, Quality Assurance for Hospital Qualifications and Regional Operations Quality including country batch release in Israel. You will work with the Quality and Commercial teams in supporting our efforts in this exciting new area of cell therapy products. You will work cross functionally to 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 executing the qualification requirements, auditing, training, monitoring and managing changes as well as acting as QP for Kite/Gilead cell therapy products. This position will be located in Israel; reporting to the Regional Quality Operations Europe and Middle East organization.

Responsibilities (include but are not limited to):

• Execute and manage the apheresis centers and treatment centers sites (ACTS) qualification process that will use risk-based tools for qualification, training and monitoring, including performing audits and trainings.
• 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.
• Assure business systems are developed, supported and maintained including approval of changes to the courier tracking and order intake systems to assure validated state of the systems is maintained for patient traceability.
• Support Quality’s collaboration efforts with Commercial in the management of the ATCS relationship and Supply Chain to ensure compliance across the Kite product Journey and best customer experience.
• Assess and report on metrics monitoring per schedule and provide updates to approved ACTS list.
• Act as Quality contact, or delegate, for ACTS issues and discrepancies, and lead/manage the investigations to resolve the issues.
• Work with Global Site Qualification and the Regional Quality Operations APAC, EME and America organizations, as needed.
• Support deviation investigations which occur during the manufacturing, packaging and shipment of products.
• Serve as Gilead QP per the MOH guidelines. Release batches Kite cell therapy product and related activities in compliance with local MOH regulations and internal SOPs and supervise quality/regulatory aspects of distribution in Israel and being a contact for the MOH on related quality issues.
• Managing interactions with the Manufacturing Plant in relation to all GDP activities, new packaging and Artwork.
• Handle QA activities relating to Kite products such as complaints, deviation, Change controls, CAPA etc.
• Perform other duties as assigned.

Requirements:

• Licensed pharmacist in Israel, previously and currently
• QP qualified and approved by the MOH.
• Currently acting as a QP.
• Experience in medical, pharmaceutical or biologics quality systems’ roles; apheresis/transplant/infusion centers, blood banks, nursing, or blood/human tissue experience is preferred.
• Experience auditing blood banks, plasma centers, apheresis centers, external suppliers and/or internal GMP systems.
• Fluent in both Hebrew and English (written and spoken).
• Proficient in MS Word, Excel, and Power Point
• 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 Values

  • Integrity (Doing What’s Right)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)
  • Inclusion (encouraging diversity)

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, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.