Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. The company focusses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, they have grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

You are responsible for owning and managing temperature assessment records (TEs), as well as both minor and major deviation records, including leading root cause analysis sessions. You oversee CAPA and CAPA Effectiveness Verification (EV) records, ensuring they are implemented as intended. Your role includes managing missing product notifications and, when applicable, leading Event Review Team meetings. You support audits and inspections related to the EU supply chain, including those conducted at the affiliate level, and contribute to product recall activities and annual mock recall exercises. Incidental travel may be required to fulfill these responsibilities. Additionally, you ensure that Smartsheet trackers for deviations, temperature excursions, and missing products are consistently up-to-date. As a Subject-Matter Expert (SME) in document management control, you provide guidance and oversight to maintain compliance and operational excellence.

To succeed in this role, you will need a bachelor’s degree or equivalent in Life Sciences, along with at least 2 years of experience in GMP/GDP compliance. If you do not hold a Life Sciences degree, you will need a minimum of 4 years of relevant experience in GMP/GDP compliance. You will need a solid understanding of Quality Assurance principles, as well as Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Fluency in English is required, and Dutch language skills are preferable. You will also need strong proficiency in word processing, database, and spreadsheet applications, along with experience using Quality Management Software systems such as TrackWise or Veeva.

NOTE: This role is for 12 months duration. In this position, you will get a competitive salary and your travel expenses are covered.