Qualified Person (QP)

Qualified Person (QP)

Office: Kiryat Gat, Israel | Location: On Site

• Company: Gamida Cell, Ltd.
• Posting Title: Qualified Person (QP)
• Function: Quality
• Division: Quality Kiryat Gat
• Location: On Site

Gamida Cell is a leader in advanced cellular therapies and hematopoietic stem cell transplantation, with two FDA approved therapies, Omisirge® (omidubicel-onlv) and APHEXDA® (motixafortide). Omisirge® is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy that is potentially curative for patients with hematologic malignancies. APHEXDA® is a CXCR4 antagonist with long receptor occupancy indicated in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

General Scope and Summary

As the Qualified Person (QP), you will play a pivotal role in ensuring that our products meet the highest standards of quality and compliance. You will be responsible for batch certification and release, and act as a key quality authority within the company. This is a hands-on role that requires close collaboration with cross-functional teams and a proactive approach to problem-solving.

Roles and Responsibilities

• Certify and release batches of investigational and commercial batches.
• Ensure compliance with regulatory requirements, internal procedures, and quality standards.
• Review and approve batch records, deviations, CAPAs, and change controls.
• Provide quality oversight for manufacturing, testing, and packaging activities (in-house or outsourced).
• Support tech transfer, validation, and scale-up activities from a quality perspective.
• Participate in audits and inspections, and lead preparation and response efforts.
• Act as a quality ambassador, fostering a culture of compliance and continuous improvement.
• Collaborate with Regulatory Affairs, R&D, and external partners to ensure alignment on quality expectations.
• Other related duties, as assigned by direct manager

Experience, Education and Specialized Knowledge and Skills

• Degree in Pharmacy,
• Eligible to act as a QP in Israel- advantage
• Experience in pharmaceutical or biotech industry, ideally in a GMP environment – advantage
• Understanding of FDA EU GMP, ICH guidelines, and biotech manufacturing processes- advantage
• Fluent Hebrew and English
• Experience with clinical trial materials and/or biologics is a plus
• Experience with blood and or blood products