Gmp Quality Operations Specialist

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.