Associate Director, Head Of Imp Quality

Takeda

Lexington, MA, USA
Base: $154,400.00 - $242,550.00; bonus/equity: u.s...
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Lead quality operations for imps
Ensure compliance with global regulations
Define quality standards and oversee audits
** Takeda is seeking an Associate Director, Head of IMP Quality, to oversee quality operations for investigational medicinal products, ensuring compliance with regulations and leading a skilled team. The role involves strategic leadership, process improvement, and collaboration with various stakeholders to support the company's mission of delivering high-quality therapies. **

Job Summary

  • This role provides strategic, industry-leading oversight of Takeda’s quality processes, ensuring compliance with global regulations, cGMP standards, and corporate policies.
  • As the head of a highly skilled team, you will define quality standards, oversee audits, manage deviations, and lead process improvement initiatives.
  • Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Matching Summary

Match Score: 75

** Takeda is seeking an Associate Director, Head of IMP Quality, to oversee quality operations for investigational medicinal products, ensuring compliance with regulations and leading a skilled team. The role involves strategic leadership, process improvement, and collaboration with various stakeholders to support the company's mission of delivering high-quality therapies. **

Salary

Base: $154,400.00 - $242,550.00; Bonus/Equity: U.S. based employees may be eligible for short-term and/or long-term incentives; Benefits: medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

Skills & Requirements

Must-have

  • Lead quality operations for IMPs
  • Ensure compliance with global regulations
  • Define quality standards and oversee audits
  • Manage deviations and lead process improvement
  • Review, approve, and release clinical trial materials

Nice-to-have

  • Continuous professional development
  • Build strong cross-functional relationships
  • Deliver high-quality, safe, and effective therapies

Key Requirements

  • Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or related field
  • Minimum of 7 years of experience in pharmaceutical manufacturing, packaging, laboratory, or QA/QC/compliance
  • Proven leadership experience with ability to motivate, mentor, and develop teams
  • In-depth knowledge of international regulatory requirements and cGMP practices
  • Strong analytical, problem-solving, and decision-making skills
  • Excellent communication and collaboration skills
  • Willingness to travel up to 10%

Work Rights

Not specified

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