Your new role
As a QA Manager GLP, you are the QA responsible for the GLP facility of your employer in Utrecht. On a daily basis, you are:
• Maintaining a suitable quality framework ensuring GLP compliance;
• Conducting applicable QA activities in accordance with regulatory requirements and authority expectations, e.g. facility audits and study audits;
• Ensuring quality oversight activities of suppliers and vendors as well as computerized systems (in collaboration with IT QA) used for GLP activities;
• Ensuring implementation of global processes and systems in the GLP facility;
• Providing general QA support of GLP personnel, including relevant training activities;
• Planning and managing authority inspections;
• Building and maintaining quality awareness and supporting GLP/BioA organization on quality aspects;
• Supporting GLP activities in Non-Clinical Safety Plan, conducting, reporting and following-up internal audits, external CRO audits and study audits according to procedures;
• Ensuring that your employer’s non-clinical safety studies and GLP work are conducted in compliance with GLP and other regulatory requirements;
• Providing internal GLP training.

Your profile
If you want to be a successful QA Manager GLP, you need to have at least a Master’s degree in a Life Science field such as Biology, Biotechnology, Pharmacy or similar. PhD graduates are also welcome to apply. You combine your degree with at least 5 years of relevant working experience in GLP QA, ideally in a bigger size organization, as your new employer is also quite big. You are fluent in English, Dutch is not mandatory for this position. Because it’s an international working environment, you will be required to travel internationally (EU / US) for about 20% of your time. Of course, this will be planned in advance so you can align with your personal life.
As a person, you are highly capable of engaging with different stakeholders and you are able work effectively in a global organization. If you recognize yourself, please apply now! #1045232