Présentation de l’entreprise
Our client is a premium employer with a exceptional reputation in the market and an excellent work environment. Based in a location that is easily commutable from Brussels, this company can also offer you chance to develop your career.
Description de la mission
Based at the manufacturing and head office site just South of Brussels this global Bio Pharmaceuticals business is looking for a Senior Manager – Bio statistics to join and lead a newly created team to support the business with day to day needs as well as regulatory projects from a Statistical data aspect.
Your responsibilities will be;
* Managing a team that is accountable for providing statistical support to the business and quality operations on the site including planning and coordination of statistical activities, management of deliverables and priorities, training & coaching.
* Developing a statistical strategy used for the validation of analytical methods, for process validation, determination of specification, rules for product consistency follow-up and for testing parameters follow-up.
* Developing harmonised and validated statistical tools & solutions.
* Troubleshooting in line with the business needs by providing support to investigations in the context of deviations and improvement projects.
* Analysis of scaling-up and manufacturing data to support product registration or product variation, support during inspections by regulatory authorities.
* Supporting key business projects implementing new statistical approaches and innovation in the business. Increase of statistical capability within group by giving trainings and developing tools to harmonize the collection, analysis, report and interpretation of data.
This is a great opportunity to have an impact on a statistical role and the support it offers the business. As Senior Manager – Bio statistics. You will join a Bio Pharmaceuticals business that has grown and will grow.
* At least 8 years in the pharmaceutical industry with significant experience in statistics applied in Quality Control or Manufacturing environment.
* Demonstrable leadership and people management skills
* Deep knowledge of pharmaceutical manufacturing environment, including excellent understanding of the framework within which a product has to be developed and maintained in compliance with specifications and regulatory requirements.
* Strong theoretical background and practical application of designs of experiments, multivariate analyses, complex mixed effect models, statistical process control on a wide variety of business issues Very good command of statistical packages
Niveau de qualification
- Type de contrat CDI
- Rémunération A négocier