Associate Director, Head of IMP Quality
Takeda
6 hours ago
Remote friendly (Lexington, MA)
United States
$154,400 - $242,550 USD yearly
Operations
Associate Director, Head of IMP Quality
How You Will Contribute:
- Provide strategic leadership and oversight of a team of QA managers, ensuring continuous professional development and operational excellence.
- Review, approve, and release clinical trial materials, including batch records, analytical protocols, and packaging labels.
- Ensure compliance of Takeda’s development products with regulatory requirements, cGMP, and Takeda Quality standards.
- Ensure adequate investigations of quality issues and implement corrective and preventive actions to prevent recurrence.
- Support regulatory submissions, pre-approval inspection readiness, and external audits.
- Drive continual improvement initiatives and process optimizations to enhance operational efficiency.
- Build strong relationships across internal stakeholders, partners, and external suppliers to achieve agility for pharmaceutical development and high-quality outcomes.
Skills and Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field (advanced degree preferred).
- Minimum of 7 years of experience in pharmaceutical manufacturing, packaging, laboratory, or QA/QC/compliance environment.
- Proven leadership experience with the ability to motivate, mentor, and develop high-performing teams.
- In-depth knowledge of international regulatory requirements and cGMP practices.
- Strong analytical, problem-solving, and decision-making skills in complex, global environments.
- Excellent communication and collaboration skills; ability to influence cross-functionally at all levels.
- Willingness to travel up to 10%, including domestic and international trips.
- Quality auditor certification preferred.
How You Will Contribute:
- Provide strategic leadership and oversight of a team of QA managers, ensuring continuous professional development and operational excellence.
- Review, approve, and release clinical trial materials, including batch records, analytical protocols, and packaging labels.
- Ensure compliance of Takeda’s development products with regulatory requirements, cGMP, and Takeda Quality standards.
- Ensure adequate investigations of quality issues and implement corrective and preventive actions to prevent recurrence.
- Support regulatory submissions, pre-approval inspection readiness, and external audits.
- Drive continual improvement initiatives and process optimizations to enhance operational efficiency.
- Build strong relationships across internal stakeholders, partners, and external suppliers to achieve agility for pharmaceutical development and high-quality outcomes.
Skills and Qualifications:
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field (advanced degree preferred).
- Minimum of 7 years of experience in pharmaceutical manufacturing, packaging, laboratory, or QA/QC/compliance environment.
- Proven leadership experience with the ability to motivate, mentor, and develop high-performing teams.
- In-depth knowledge of international regulatory requirements and cGMP practices.
- Strong analytical, problem-solving, and decision-making skills in complex, global environments.
- Excellent communication and collaboration skills; ability to influence cross-functionally at all levels.
- Willingness to travel up to 10%, including domestic and international trips.
- Quality auditor certification preferred.