As a Senior Consultant of the Engineering & Technical Support Division you will often have a detailed project contract with the client, specifying your activities and the expected results. You will predominantly work on location, but also from home or from Xendo’s Leiden office. Project’s duration can vary from one week (for high level advice/gap analyses) to several months. In short: you feel comfortable in a position that allows you to apply and further increase your knowledge and expertise in the area of GxP compliance and validation. This, amongst others, is your contribution in aim to provide better products for patients.
Xendo is a consultancy and project management organisation in the (bio) pharmaceutical and medical devices and healthcare fields, meaning that your clients are operating in the life science sector. Thanks to our multi-disciplinary, knowledge driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects that we participate in. For over 25 years, we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations.
IT & Automation within the Engineering & Technical Support Division, reporting to the managing consultant.
Who we are looking for:
Those who dare to make the difference – in the way they act, collaborate and lead. As Senior Consultant you will have the opportunity to share your extended knowledge in the field of IT & Automation with Xendo’s clients and closely collaborate with colleagues across divisions. Addressing new challenges and finding innovative solutions is your prerogative. Mostly working on-site, at the client's premises, you welcome independent responsibility for your projects.
As a Senior Consultant you will be assigned to (IT) compliance projects within the pharmaceutical, medical devices and life sciences industries. You will mainly work in laboratory, production and validation departments, so knowledge of and experience in these departments is an advantage. Knowledge of GxP and validation combined with a feeling for IT and compliance is a requirement. Your job is to contribute to improving or establishing the clients’ (IT) compliance by providing them with the best possible assistance with their issues. As a Senior Consultant you work on validation projects as project manager, high level consultancy projects in which you advice the client on the validation strategy for implementing IT solutions or interim management functions. In these roles you need besides in-depth knowledge about GxP compliance, good communication skills, persistence and an agile working attitude.
- Bachelor’s or Master’s degree;
- at least 5 years of experience with GxP compliance and validation in the life sciences sector;
- experience with validation of computerized systems
- good communication skills and interpersonal skills;
- client-oriented, dedicated, flexible, proven project management skills with helicopter view and able to quickly switch between different assignments
- good understanding of GAMP, Annex 11 and 21 CFR Part 11;
- excellent in both Dutch and English language.
Please contact Joost Havers, Managing Consultant at +31 71 524 40 00 or by e-mail for additional information on job specifics.
- a dynamic and varied position in a fast-growing and professional company;
- good terms of employment;
- focus on continuously extending knowledge and experience;
- great projects in all aspects of GxP compliance and validation;
- projects at both small and large life science organisations and suppliers.
If you are interested in this position, we encourage you to send your motivation and CV to us