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Head of Quality Operations

  • Job type: Permanent
  • Location: Frankfurt am Main
  • Salary: Competitive
  • Job reference: Head of QA Ops
  • Sector: EPM Scientific, Quality
  • Date posted: 30/10/2017
The Company

Head of Quality Operations

My client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. In 2017, they are rapidly expanding and their current site in Frankfurt has the potential to grow into a more global and senior position within the next few years. 


 


The Role

Head of Quality Operations

The scope of the position encompasses oversight of all aspects of quality support, including Market Release, Regulatory Compliance, FDA Inspections, Market Complaints, Product Recalls and support for Product Development, Product Site Transfers and Product Launches my client’s franchise. Maintain Quality Oversight of Contact Person for Vendors, Third Party Manufacturers (TPMs) and Affiliates to ensure the company’s interests are met and that relationships are properly maintained. Manage the Vendor, TPM Audit Program, Technical Agreements and Quality oversight of in-House Operations relating to the US market. Manage the Change Controls, Deviations, Batch Records Review and Release of Finished Product into the US market for TPM product.



Job Requirements

  • Established Quality Assurance Management background
  • GMP & GLP experience essential
  • Experience with FDA & European regulatory requirements, guidelines, and expectations
  • Experience building a team
  • BSc or MSc in Pharmaceuticals/Biochemistry/Biomedical
  • Fluent English essential
 


If this a position you are interested, please submit a copy of your most up-to-date CV on Microsoft Word format to;


apply.a33ho1gjg81@epmscientific.aptrack.co.uk


Or Call;


+0044 203 758 8784


 


Nicky Walsh


Head of Quality Management for EPM Scientific, Germany


 


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