Validation manager/director

Ref. 20181112
Function: The validation manager/director is a member of the CREATE sphere and reports to the senior director R&D operations.
Location: Operating in Mechelen. Occasional travelling (to USA site, +/- 4 times a year).

The company:

The company is an innovative commercial stage molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. The Company’s proprietary platform is a fully automated, real time system which offers accurate, highly-reliable molecular information from any biological sample in virtually any setting. It addresses the growing demand for personalized medicine by allowing fast and effective treatment selection and treatment progress monitoring.

The company is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest and largest growing segments of the US$5 billion MDx market which is expected to grow to approximately US$8 billion in 2018.

Job description:

The validation manager/director manages the company's validation team, a group of experts that is responsible for analytical and clinical validation of the assay, platform validation and biostatistics across different product development projects. The validation team members are based in Belgium and USA.

- The validation manager/director represents the validation team (8 members, masters and PhDs) within the company's CREATE sphere and aligns the team capabilities with the business needs. The team will be expanded at the USA site.
- The validation manager/director creates a context that stimulates initiative and continuous improvement for the team members within the highly regulated and fast-moving business context.
- The validation manager/director ensures optimal project assignment and competency management for the validation team.
- The validation manager/director defines processes and organizes meetings to support optimal functioning of the (global) validation Team.
- The validation manager/director oversees overall analytical and clinical validation activities in support of US FDA and CE-IVD registration of the company’s IVD products and supports the team to secure project delivery.
- The validation manager/director takes responsibility for overall biostatistics services and supports the team to secure project delivery.
- The validation manager/director is responsible for the development, roll-out and maintenance of operational processes and tools conform applicable IVD regulations, in the area of analytical and clinical validation as well as biostatistics.

Requested competences and skills:

Master degree in a scientific orientation or equivalent through work experience, PhD is a plus.

- +5 year-work experience in the healthcare industry, of which min. 3 years in a people management role.
- Proven track record in people management is required.
- Knowledge of IVD development and validation processes.
- Knowledge of IVD regulations (experience with FDA PMA submissions is strongly preferred).
- Experience with remote team is a plus as half of the validation team is located in the USA.
- Leadership.
• Support extraordinary team work
• Excellent communication skills
• Conflict resolution skills
- Methodic and process minded.
- Well developed presentation skills.
- Result- and improvement-oriented.
- Open-minded and dynamic.
- Perfect English written and spoken.
- Experience with statistical computing software is a plus.
- PC skills: MS office.


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