• 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.

• 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)