Eurofins Amatsigroup is one of the leading CDMOs in Europe providing high-quality, customized drug development solutions for specialty and biopharma clients. Our focus is to support clients on the earliest phases of their development pathway (from API to the clinical packaging).
With approximately 350 staff worldwide, we operate out of 6 sites either in France and Belgium. To support our ambitious growth plan, we are today looking for a Director Corporate Quality for our sites in France and Belgium.
Position: Director Corporate Quality
The Director Corporate Quality will report to the Eurofins Amatsigroup Managing Director for France and Belgium and will interact with the QA Managers of the 6 sites across the company. The Director Corporate Quality will be a member of the global CDMO management team.
Your main responsibilities are:
Develops, drafts and manage procedures related to Eurofins Amatsigroup Corporate Quality System
Interfaces with the QA managers of the different locations to ensure that all operations at the different locations comply with the Eurofins Amatsigroup Corporate Quality and with the applicable local and current EMA regulations
Effectively partner with the local QA managers to ensure proactive identification, resolution and prevention of quality related issues
Provides leadership and decision making in managing situations and issues related to the Corporate Quality System
Plans, schedules and executes a QMS internal audit program encompassing all company locations to ensure Corporate Quality requirements are met
Communicates the results of the QMS internal audits to the CDMO management team, Managing Director and the QA managers of the different locations and proposes remediation activities
Coordinate and follow up the remediation activities
Develops metrics to measure effectiveness/progress in overall Corporate Quality compliancy
Competences and education:
Master of Science degree in pharmaceutical sciences, chemistry, biochemistry or related discipline
10 years of quality assurance experience in the pharma and/or biotech industry, preferably at the corporate level. Multi-site experience is a plus.
Strong leadership skills
Strong decision making and problem-solving skills
Working knowledge of ISO, EMA and US FDA quality system and regulatory requirements associated with the services provided by Eurofins Amatsigroup
Supervisory and auditing experience, ability to lead internal audits
Excellent organization, facilitating and coordination skills. Ability to work independently as well as a member of a team in a dynamic and fast-paced environment
Able to identify problematic situations, to communicate appropriately, to initiate problem solving processes and to propose remedial actions
Excellent oral communication, reporting and presentation skills
Must be able to travel up to 50% of the time. Travel will be primary to the different Eurofins Amatsigroup locations
Fluent in English, written and spoken. Knowledge of French is an advantage.
We offer you:
A position with responsibility within a dynamic company
Working in an innovative and international environment together with a dynamic team.
Professional and personal development is supported.
Sustainable and meaningful approach in everything we do.
A salary, depending on your experience, based on market practice.
Competitive bonus plan.