Head of Global Research Quality; Non-Clinical

Job Description

Objective /

Purpose:

The Head of Research Quality holds the highest leadership role within the Research Quality organization and serves as a key member of the R&D Quality leadership team. This executive is fully accountable for defining and executing the global strategic vision for Research Quality, overseeing a global team of experienced subject-matter experts dedicated to ensuring integrity, compliance, and ethical excellence in non-clinical research activities, studies, and processes supporting Takeda’s R&D pipeline.

Through strategic leadership, impactful stakeholder engagement, and championing an enterprise-wide quality culture, the Head of Research Quality drives organizational success and reinforces Takeda’s commitment to industry-leading standards.

Accountabilities:

• Establish and implement a comprehensive global strategic vision for Research Quality, ensuring sustained and impactful contributions to the enterprise. Align this vision with the overarching goals of Research and R&D Quality leadership.
• Design oversight strategies and effectively deploy resources to mitigate compliance risks for Research non-clinical studies conducted externally in non-OECD Mutual Acceptance of Data system countries.
• Cultivate influential relationships with key stakeholders to maintain an in-depth understanding of R&D and Research strategies
  . Leverage this insight to proactively anticipate and address impacts on Research Quality, driving business growth and success.
• Direct the Research Quality function in designing, implementing, and refining processes that ensure Takeda’s non-clinical Research activities are conducted with the highest integrity and compliance with Takeda standards and global regulatory requirements.
• Architect strategies to foster a culture of continuous improvement, leading initiatives across internal stakeholder groups to uphold quality, compliance, and data integrity throughout Research programs and projects.
• Spearhead digital transformation and the adoption of cutting-edge science and technology to support data-driven processes and decision-making within Research Quality.
• Mentor and empower direct and indirect reports across Research Quality, promoting personal development and driving high-performance teams.
• Develop and sustain collaborative relationships with Research leaders to facilitate productive discussions and align strategies and priorities.
• Provide strategic oversight to enhance capabilities, mechanisms, and processes for proactive quality risk management across the global Research organization’s activities and programs.
• Maintain and expand knowledge of global regulatory requirements and trends, identifying gaps and implementing solutions to position Takeda at the forefront of industry expectations.
• Implement strategies for the ongoing development and success of Research Quality, including talent development, succession planning, resource allocation, and budget management, aligning initiatives with R&D Quality and Global Quality.
• Offer strategic input to the R&D Quality Leadership team on key goals, initiatives, resource planning, and budgetary considerations, ensuring alignment with organizational objectives.
• Drive strategic alignment and successful achievement of shared goals through collaboration with other functions in R&D Quality and Global Quality.
• Identify areas of risk and improvement, presenting solutions to address these challenges effectively.
• Undertake additional duties as assigned, contributing to the overall success of the organization.

Education & Competencies (Technical and Behavioral):

• Minimum requirements:
  • Bachelor’s Degree in Chemistry, Biology, Engineering or related field
  • 12+ years of increasing responsibility and experience in the biopharma/biotech industry
  • 8+ years of Quality/Compliance experience
  • Prior management experience

• Preferred requirements:
  • Advanced degree in Chemistry, Biology, Engineering or related field
  • Experience working in biopharmaceutical research

• Desired skills & competencies
  • In-depth knowledge of global regulations governing biopharmaceutical research, with the ability to effectively translate and articulate strategies to ensure compliance.
  • Proven…