Over de functie
With the exciting stage of its growth, Fagron is now looking to recruit a highly experienced leader to the role of Global Quality Director. This is a critical leadership position responsible for the establishment of the strategic direction, achievement of major objectives, and overall leadership of the Quality function within Fagron.
The Global Quality Director will work at the Global Service Center in Rotterdam (the Netherlands) and will report to the Chief Operations Officer.
To accomplish this, he/she has to work on a diversity of tasks, which are listed in a number of job specifications.
Tasks and Responsibilities:
- Establish Fagron’s dedicated quality system
- Define the global quality standard with the aim to establish a common global standard at global, regional and local level
- Manage directly a small global quality team, based in Rotterdam and Shanghai, and indirectly monitor all local Quality departments within the Fagron Group
- Ensure GDP/GMP compliance through internal and external audits, supported by Fagron’s quality team
- 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 global, regional and local level
- Define training needs (global, regional, local) and monitor and oversee execution of training (in-house) in co-operation with regional and local quality teams
- Support Business Development units globally with regards to RFQ, RFI and RFQ responses for all quality and quality process related matters
- Support client facing activities such as audits and high-level meetings
Maak het verschil
In order to meet the requirements for this interesting and challenging opportunity, the company will be looking for a Global Quality Director with the following background and qualifications:
- Degree level education in pharmacy
- 5+ years of (international) experience in pharma product development or quality control or related positions in pharma industry
- Proven experience in a similar role
- Ability to demonstrate successful quality management and development record
- Excellent negotiation, presentation and communication skills
- Excellent project management skills
- Skilled to work in a matrix organization
- Results focused
- Ability to work on holistic solutions and translate them into business solutions
- Experience in a changing context / change management
- Have the ability to communicate internally and externally at a variety of levels up to Board level
- A high level of international travel will be required to successfully execute the role
- Sufficient Management experience
- Sound knowledge of GMP/GDP within international quality and regulatory guidelines
- Fluent in English is mandatory, Dutch is desired
Wat bieden wij?
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.