Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan. As Japan's largest pharmaceutical company, Takeda is committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines in 80 countries and regions worldwide. The company focuses its research on the therapeutic areas of oncology, gastroenterology, diseases of the central nervous system and rare diseases. Takeda also makes targeted investments in research activities in the areas of plasma-based therapies and vaccines. More than 2,500 employees work for Takeda at its four locations in Germany. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission for people worldwide.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
GMP Quality Manager (f/m/d)
Your Accountabilities
- Responsible for day-to-day interactions with contract facilities (CMOs) Ensure cGMP requirements and Takeda expectations are fulfilled for activities at contract facilities.
- Conduct investigations for issues associated with audits, batch records and complaints. Approve manufacturing and testing deviations and investigations into out-of-specification results
- Review and approve batch production records and test records
- Create CoAs and support batch disposition for further manufacturing
- Provide support for tech transfer
- Review and approve documentation for tech transfer and validation of analytical methods and manufacturing processes
- Conduct audits at CMO, testing, packaging, and warehouse/distribution operations and internal audits
- Provide support for regulatory submissions
- Maintain QA records according to applicable regulatory requirements and Takeda policy
Your Profile
- Bachelor’s Degree or higher in Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline
- Several years of experience in quality assurance within the pharmaceuticals, biologics
- GMP-experience, or experience in other regulated industry
- Experience with supporting product inspections from global Regulatory Authorities is required
- Experience with pre-approval inspections and bringing products to commercialization is required
- Effectively represent Quality Assurance, both internally and externally.
- Excellent communication skills both oral and written
- Experience in routine office software packages and specialized software applications as appropriate
