Company: SIRE Life Sciences
Location: Utrecht

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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Biotechnology organisation, based in Utrecht Netherlands.


The Company

In the Netherlands they are a relatively small office with much growth potential. This Biotech company is dedicated to improving the lives of patients fighting rare diseases. There mission is to make a real difference to patients by developing new medicines.

Role Description

Responsible for Quality and Regulatory Compliance for GDP (and GMP) in Europe.

Responsibilities

  • Oversee QA program in Europe; this includes establishing and maintaining the required licenses for distribution activities in Europe;
  • Provide Quality oversight including performing audits and establishing Quality agreements
  • Quality operations compliancy
  • Increase the overall effectiveness of the Quality department together with other departments
  • Auditing intern and extern
  • Establish and maintain a risk-based and scientific-based quality system
  • Assist in other quality assurance related activities as agreed with management.


Requirements

  • GDP’s and cGMPs.
  • At least 8 years of QA experience in regulated industry such as pharmaceutical, biologics or device.
  • Minimum MS degree in Pharmacy, Chemistry, Life Science or related discipline.
  • Must have excellent communication skills (verbal and written).
  • Fluent in English. Knowledge of other European languages are a plus.
  • This position should be located in the Netherlands and relocation considered. Approximately 30% travel.