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Quality Vendor Manager
Office: Kiryat Gat, Israel
- Company: Gamida Cell, Ltd.
- Posting Title: Quality Vendor Manager
- Department: Compliance, QMS & Field
- Function: Quality
- Reports to: Vice President, Quality
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
The Quality Vendor Manager is responsible for leading and executing all vender related activities that are required under cGMP. That includes qualification, maintenance, and auditing of all GMP venders, service providers and consultants. Additionally, the Quality Vendor Manager is a part of the quality team and as such is part in setting the quality standards and culture for GC.
Roles and Responsibilities
- Implement the supplier, contract giver and consultant qualification program at Gamida Cell
- Perform supplier quality assessments, measure supplier performance through routine trend analysis of established supplier quality metrics
- Perform supplier quality audits; create audit reports; follow up on resulting supplier responses and corrective actions
- Manage supplier complaints; ensure completion of investigations and corrective actions, as needed
- Initiate and manage Supplier Quality Agreements; maintain approved supplier list
- Evaluate impact of supplier change notifications; manage change controls if product/material specifications are impacted
- Support the management of non-conforming material related to supply chain and vendor issues; notify and escalate any potential quality or regulatory issues
- Write and approve SOPs related to vendor qualification. Support SOPs related to supply chain, raw material specifications and methods SOPs.
Experience, Education and Specialized Knowledge and Skills
- Bachelor’s degree or higher in science-related field, or equivalent work experience
- Professional experience in pharmaceutical industry and Quality Assurance (Minimum of 5 years)
- Experience within Supplier Quality in a biopharmaceutical setting (minimum of 3 years) – a significant advantage
- Knowledge and experience with: ISO 13485, 17025, or other industry QMS Standard is preferred
- Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook)
- Knowledge of FDA, ICH, USP guidelines, cGMP regulations
- Knowledge of Israeli MoH regulations is a plus
Apply for this Job
Gamida Cell has become aware that individuals have been contacted via social media offering employment within Gamida Cell.
We would like to inform you that this approach is not related to Gamida Cell. If you receive any suspicious requests, please do not respond. We strongly advise you not to share any personal information. Do not deposit any received cheques and do not remit money on any account. To be considered for a position of employment at Gamida-Cell, we require a complete interview process and in person communication with the hiring manager and one other permanent employee. At no point in the recruitment process do we solicit personal financial information or payment from applicants. Such requests should be considered fraudulent and reported to the police immediately.
