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/
- 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
- 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