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Director of Quality Assurance
2 months ago
We are seeking a highly experienced and skilled Director of Quality Assurance to join our team at Takeda Pharmaceutical. As a key member of our Quality Control Laboratory, you will be responsible for managing, planning, organizing, directing, and evaluating all activities and staff to ensure the safety and reliability of our products, and to comply with Quality and Regulatory requirements.
Key Responsibilities:- Manage and Lead: Direct and evaluate all activities and staff of the Analytical Chemistry Department in the Quality Control Laboratory.
- Quality and Regulatory Compliance: Ensure compliance with Quality and Regulatory requirements, including FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines.
- Testing and Quality Control: Work with manufacturing and product support teams to ensure product safety through Testing of Raw Materials, Critical Systems, In-Process Intermediates, and Finished Drug Products.
- Continuous Improvement: Support Quality Control Programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant goals.
- Regulatory Inspections and Audits: Represent the Quality Laboratory during Regulatory Inspections and Customer Audits.
- Assay Troubleshooting and Support: Lead troubleshooting activities for assays issues and support complex investigations.
- Regulatory Filings and Submissions: Support regulatory filings, submission review, and data analysis.
- Team Management: Manage a large team of employees, including hiring, training, and performance evaluation.
- Operational Budget Management: Manage the operating budget for the lab/teams.
- Continuous Learning and Development: Stay up-to-date with the latest developments in Quality Assurance and Regulatory Compliance, and apply this knowledge to improve laboratory operations and processes.
- Education: Bachelor's Degree in Chemistry or Biological Science.
- Experience: 8+ years of related experience, with 3+ years in a management role.
- Skills: Advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP, and GDP.
- Physical Demands: Ability to lift, push, pull, and carry up to 15 lbs.
- Travel: 5% travel required.
Takeda Pharmaceutical is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment.
