Head of Research Quality (Sr Director / Non-Clinical)

Takeda • Boston, MA

22h • Onsite

About The Position

The Head of Global 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.

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
• In-depth knowledge of global regulations governing biopharmaceutical research, with the ability to effectively translate and articulate strategies to ensure compliance.
• Proven leadership, collaboration, and influencing skills, coupled with a demonstrated ability to solve problems and drive impactful change.
• Proficiency in working with diverse individuals across all organizational levels.
• Exceptional interpersonal, verbal, and written communication skills, enabling successful interaction with internal stakeholders and vendors.
• Adaptability and flexibility to thrive in dynamic environments, along with the ability to manage and deliver multiple projects on time.
• Strong attention to detail and organizational expertise, with a capacity to work independently across global settings and navigate organizational complexities.

Nice To Haves

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

Responsibilities

• 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.

Benefits

• U.S. based employees may be eligible to participate in 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.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees