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Director, GMP Operational Quality (On-site) page is loaded Director, GMP Operational Quality (On-site) Apply locations Boston, MA time type Full time posted on Posted Yesterday job requisition id REQ-21657 Job Description
General Position Summary :
The GMP Quality Operations Director serves as a Quality leader
Executive Director, Quality Assurance, GMP Boston, MA, USA Req #267
Monday, May 13, 2024
Who We Are:
Who We Are:
Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and p
Job Source: Xenon Pharmaceuticals Inc.
GMP Quality Operations Specialist
Boston, MA, United States
Our Pharma client is currently searching for a Quality Operations Specialist with expertise in both development and commercialization of products.
The primary responsibility of this position will be to ensure quality oversight of assigned projects/CMO's for the clinical/commercial product manufactured and to work cross-functionally providing updates and meeting complex timelines for mission critical deliverables.
Qualified applicants will have the following skill sets:
•B.S. degree in Life sciences, chemistry or equivalent.
•5+ years of GMP Quality experience with focus on cGMP compliance and product quality for US and EU. Drug Substance.
•Experience with using risk-based principles and decision making to ensure compliance at all stages of development.
•5+ years of experience with relevant US, EU and ICH requirements.