About the job
Fagron has offices in more than 30 countries around the world and is rapidly growing. To accelerate our growth strategy, we are continuously looking for talented professionals. For our Global service center in Rotterdam, we are looking for an EMEA Quality Manager.
The EMEA Quality Manager will report to the Global Quality Director. He/She will be part of the Global Quality team to support our global strategy in the region. The team members are based at sites in EMEA.
What will you do?
- Establish Fagron’s dedicated quality system
- Manage the quality team based in EMEA
- Ensure GDP/GMP compliance through internal and external audits, supported by Fagron’s quality team
- Drive quality compliance across Fagron locations and ensure preparedness for any external audit
- Perform internal audits of Fagron companies across EMEA
- Support local quality departments to take action on any audit findings, to reinforce compliance or remedial action on any unsatisfactory findings
- Ensure that procedures, their proper application and systems are in place for Supplier Qualifications
- Ensure that the quality standard meets or exceeds global and local guidelines such as but not limited to GDP, GMP, FDA
- Create and govern Fagron’s manual and supportive documents such as SOPs, SLA, CAPA, RRA, Etc. at regional and local level
- Define training needs and monitor and oversee execution of training (in-house) in co-operation with regional and local quality teams
- Support client facing activity such as audits and high-level meetings
- Liaise with relevant governmental bodies, industry groups, etc.
Set yourself apart
We will be looking for a EMEA Quality Manager with the following background and qualifications:
- Degree level education in a pharmaceutical-related discipline
- 7+ years of work experience in quality control, pharma product development or related positions in the pharma industry
- Ability to demonstrate successful quality management and development record
- Sufficient management experience
- Excellent negotiation, presentation and communication skills
- Excellent project management skills
- Skilled to work in a matrix organization
- Results focused
- Sound knowledge of GMP/GDP within international quality and regulatory guidelines
- Fluent in English is mandatory, other language skills preferred
What’s on offer?
We offer a unique working environment where talent and ambition can develop to its fullest.
We have an open and informal organization culture, where you need to be able to work independently. Fagron is a young, professional and ambitious company with plenty of growth opportunities and we will offer you a competitive compensation.