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Head of Quality Europe, Qualified Person

  • Job type: Permanent
  • Location: South Holland
  • Salary: €100000 - €150000 per annum
  • Job reference: 546130/002_1528886916
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 13/06/2018

Head of Quality Europe, Qualified Person

A start-up affiliate in the bio-pharmaceutical area is hiring a Head of Quality Europe, QP, to build out their European operations from the Netherlands. Due to the recent Brexit vote in the UK, and the EMA's decision to relocate to Amsterdam, my client has decided to relocate their European Head-Quarters and Operations to the Netherlands. You will be the primary Quality contact in Europe for my client and liaise with regulatory agencies (FDA, EMA) and regularly conduct site-inspections.

You will be responsible for the release of parental bio-pharmaceutical products for investigational products (phase I-III) and medicinal products in accordance with regulatory authorisations, EU regulatory requirements, applicable quality agreements, and commercial agreements with my clients marketing partners. They are developing medicines focused on immunology, oncology, and metabolic diseases.

Responsibilities:

  • Lead regulatory inspections and responsible for the regular update and revision of MIA Licence
  • Assure all products manufactured by my client and third-party contractors fully comply with cGMP regulations
  • Assure as EUQP all products of insufficient or dubious safety, quality and/or efficacy are not distrusted

Requirements:

  • Certified EU QP
  • +10 years of experience releasing bio-pharmaceutical products
  • Thorough knowledge of FDA/EMA regulations
  • GMP/GLP Experience

Package:

  • Salary ranging 120,000 - 150,000, depending on candidate experience
  • Bonus Incentives

Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: or phone +44203758831

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