Director, Quality Assurance

Department: Quality Assurance and Control
Location: Incyte Biosciences Technical Operations SÓrl - Yverdon

 

Summary

Leads and manages the Quality Assurance activities of the bio-manufacturing plant under cGMP regulations for clinical and commercial supply of biological API. Provides leadership, direction and oversight to the associated team.  Responsible to meet financial and quality performance goals.  

Initially, this position will be responsible for the Quality Assurance oversight of the manufacturing activities during the design, construction and startup of a new green-field, large scale manufacturing facility.  Responsibilities will include supporting the qualification and validation during the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new process systems and equipment utilized in the production of biopharmaceutical drug substance according to quality policies, cGMP, EU / US FDA Regulations.  

In addition, this position is accountable to establish, organise and maintain the site Quality System in order to comply with Incyteĺs corporate system and applicable regulatory requirements. 

Primary Responsibilities: 

Qualifications

Education

 

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