What are the responsibilities and job description for the Director of Quality and Compliance position at Takeda Pharmaceutical?
Takeda Pharmaceutical is a company that values innovation and excellence. As a QA Specialist II, you will be responsible for leading Quality on the Shop Floor (QOTSF) programs, ensuring compliance with cGMP guidelines, and identifying opportunities for process improvements.
Accountabilities:
- Oversee and approve Standard Operating Procedures (SOPs) and other quality documentation relevant to the Quality department and all areas of the plant
- Develop, deliver, and approve training materials related to Quality operations, ensuring agreement across all plant areas
- Manage investigations and CAPAs for the Quality department, providing oversight and approvals for compliance across all plant operations
As a QA Specialist II, you will also be responsible for collaborating with cross-functional teams to drive quality initiatives and improve overall product quality.
Qualifications:
- Bachelor's degree in science, engineering, or other related technical field
- ~6 years of related work experience
- Knowledge of FDA, EMA, CFDA, PDA Regulations, application of Good Data and Documentation Practices (GDDP), and application of current Good Manufacturing Practices (cGMP)
