Takeda is on a mission and therefore External Supply Europe Quality is seeking a Quality manager. Are you experienced in GMP, self-driven, comfortable to make decisions and ready to be challenged? Then you might be our new Quality Manager. You should be ready to travel 20-30 days per year, voluntary additional travel days would be appreciated.
External Supply Europe Quality manages contract manufacturers (mainly located in Europe) and an even larger amount of products. The span of product formulations is e.g. aseptic, sterile, tablets, capsules, liquids, patches and sprays. The products have different status Medicinal Products, Food Supplement, Medical Devices and Cosmetics. We do expect that you have experience with some of these formulations and are open to learn about the rest.
You will be part of a good supportive international group that currently consist of passionate professionals with different strengths. Working cross border, we have offices in Taastrup (Denmark) and Singen (Germany), the position of the Quality manager will be located in your preferred location.
You will be responsible a variety of contract manufacturers and the corresponding products. The primary accountabilities are:
- Face of Takeda Quality to business partner
- Negotiation of Quality Agreements with 3rd parties
- Risk reviews and decisions based on compilation of Product Quality Reviews, complaint investigations or other supplier based deviations. Change Control Coordination between internal and external stakeholders
- Participation in audits and quality meetings of contract manufacturers and contract laboratories in order to safeguard compliance (there is possibility to become a certified lead auditor)
- Support the maintenance and further development of the Takeda Quality Management System
- Participation in process improvements initiatives
You offer the following:
- Degree in natural science, e. g. pharmacy, chemistry, biology
- 5 years experience in Pharmaceutical Manufacturing and/or Quality Control and/or Quality Assurance and/or Pharmaceutical contract manufacturer management
- Excellent knowledge of GMP regulations
- Fluent in English (verbal and written)
- Profound knowledge in Microsoft Office
- Experience or interest in use of electronic tracking systems and databases
- Experience in conduction of audits would be advantageous
- Fast understanding of complex supply chain scenarios
- Excellent negotiation, collaboration and communication skills
- Ability to work in interdisciplinary and international teams
- Awareness about and being prepared to adapt to intercultural differences
- Capability of efficient planning and prioritization of tasks, ability to work independently
- Good networking in as well as outside the organization
- Pro-active mind set, Reliable, Open minded
We offer a challenging and supporting environment with excellent interdisciplinary collaboration where you are in charge of your own growth.
The position is initially limited to 3 years.