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Associate Quality Director

  • Job type: Permanent
  • Location: Amsterdam
  • Salary: Highly Competitive
  • Job reference: AQDMWLR
  • Sector: EPM Scientific, Quality
  • Date posted: 20/07/2017
Associate Quality Director


The Company


The company is one of the most respected biotechnology companies in the industry. They are at the forefront of discovery and innovation of ground-breaking immunotherapies. They pioneer transformative advances to treat challenging diseases. They provide a workplace for people to thrive and ultimately focus on Quality of work to benefit patients. They are looking for a like-minded individual to continue the challenging developments of advancing medicines in biotechnology.


 


The Role


You will be responsible for the direct management of the QA programs for compliance applicable to FDA and EMEA bodies, Standard Operating Procedures (SOP’s) and policies, and the biotech industries best practices to ensure products meet international regulations.


 


Role and Responsibilities
  • Direct on-site implementation and management of QA processes, SOPs and other quality documentation, integrating processes between the US and Europe
  • Manage all aspects of quality relationships with external vendors, including agreements, quality audits, and review/approval of manufacturing and Quality Control documentation
  • Assure product integrity throughout the supply chain
  • Manage internal training program and coordinate and/or administer GxP training
  • Identify/implement new applicable regulations and standards that apply to QA/QC activities
  • Provide quality and compliance leadership, supporting effective global integration and reporting into senior management 
 


Key Requirements
  • 6-10 years relevant QA experience in pharmaceutical and/or biotechnology companies
  • Broad-based industry understanding of quality trends and intents for Biological products
  • Strong communication
  • In-depth knowledge of multiple biologic manufacturing processes is desirable
  • Travel is required (up to 25%)
 


If this a position you are interested, please submit an up-to-date copy of your CV to;


apply.a33ho1ggv8r@epmscientific.aptrack.co.uk


Or Call;


+0044 203 758 8831


 


Matthew Lancaster


Head of Quality Management for EPM Scientific, Benelux 


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