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Associate Director, Quality Assurance
2 months ago
We are seeking a highly experienced and skilled Associate Director, 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 a team of analytical chemists and technicians to ensure the quality and reliability of our products.
- Develop and implement quality control programs to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance.
- Work closely with manufacturing and product support teams to ensure product safety through testing of raw materials, critical systems, in-process intermediates, and finished drug products.
- 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.
- Represent the Quality Laboratory during regulatory inspections and customer audits.
- Lead troubleshooting activities for assay issues.
- Support regulatory filings, submission review, and data analysis.
Requirements:
- 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.
- In general, you will have a combination of sedentary work and walking around observing conditions in the facility.
- 5% Travel.
What You Bring to Takeda:
- Advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP, and GDP.
- Strong leadership and management skills.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and prioritize multiple tasks.
- Strong analytical and problem-solving skills.
Important Considerations:
- May wear personal protective equipment (PPE) and other clean room garments daily.
- Need to remove all make-up, jewelry, contact lenses, nail polish, and artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours.
- Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
