Associate Director, Quality Control and Assurance
4 weeks ago
We are seeking a highly skilled Associate Director, Quality Control and Assurance to join our team at Takeda Pharmaceuticals. 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, as well as compliance with Quality and Regulatory requirements.
Key Responsibilities- Manage and direct the Analytical Chemistry Department in the Quality Control Laboratory to ensure the safety and reliability of Takeda products.
- 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.
- Support Quality Control Programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant goals.
- Make critical decisions to disposition raw materials, in-process, and finished product testing results for release promptly.
- Identify potential risks associated with laboratory operations and lead teams to resolve lab issues.
- Be a representative for the Quality Laboratory during Regulatory Inspections and Customer Audits.
- Lead troubleshooting activities for assay issues.
- Support regulatory filings, submission review, and data analysis.
- Bachelor's Degree in Chemistry or Biological Science.
- 8+ years of related experience with 3+ in a management role.
- Must be able to lift, push, pull, and carry up to 15 lbs.
- Ability to work in a cold, wet environment and wear personal protective equipment (PPE) and other clean room garments daily.
- Ability to work multiple shifts, including weekends, or be asked to work supplemental hours.
Takeda 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 without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws.
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