Quality Compliance Manager
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, however if you are adventurous additional travel opportunities can be offered.
External Supply Europe Quality manages a large amount of Contract Manufacturers (mainly located in Europe and some emerging markets) and an even larger amount of products. The span of product formulations is large e.g. aseptic, sterile, tablets, capsules, liquids, patches and sprays. 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 consist of passionate professionals with different strengths. We are located in Taastrup, Denmark and Singen, Germany therefor the position is open in both locations.
You will be responsible for a variety 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:
- Master degree (or comparable ) in natural science, e. g. pharmacy, chemistry, biology
- 5 years experience in Pharmaceutical Manufacturing and/or Quality Control and/or Pharmaceutical CMO management
- Excellent knowledge of GMP regulations
- Fluent in English (verbal and written)
- Profound knowledge in Microsoft Office software
- 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 where you are in charge of your own growth.
Attractive compensations and benefits package based on qualifications and results including pension scheme, health insurance, company car and mobile/home network solutions. If you have additional questions regarding the position please call Group Leader Quality Systems Kristian Byrialsen +45 4677 1532, or for more general questions about Takeda call HRBP Nanna Seidelin on +45 4677 1740. Please apply online before October 2nd 2016 via "Apply here".