Associate Director, Head of IMP Quality

Role Summary

Associate Director, Head of IMP Quality to lead quality operations for investigational medicinal products (IMPs) from clinical development through to commercialization. Provide strategic, industry-leading oversight of quality processes, ensuring compliance with global regulations, cGMP standards, and corporate policies. Define quality standards, oversee audits, manage deviations, and lead process improvement initiatives to deliver high-quality, safe, and effective therapies. Location: Lexington, MA.

Responsibilities

• 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 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.

Qualifications

• Required: Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field (advanced degree preferred).
• Required: Minimum of 7 years of experience in pharmaceutical manufacturing, packaging, laboratory, or QA/QC/compliance environment.
• Required: Proven leadership experience with the ability to motivate, mentor, and develop high-performing teams.
• Required: In-depth knowledge of international regulatory requirements and cGMP practices.
• Required: Strong analytical, problem-solving, and decision-making skills in complex, global environments.
• Required: Excellent communication and collaboration skills; ability to influence cross-functionally at all levels.
• Required: Willingness to travel up to 10%, including domestic and international trips.
• Preferred: Quality auditor certification.