Head of Research Quality (Sr Director, Non-Clinical, Pre-Clinical Research)

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Job Description

Objective / Purpose:

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 Takedas 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 Takedas 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 Takedas 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 organizations 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:
  • Bachelors 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 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.

#GMSGQ #ZR1 #LI-LR1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. 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.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

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Job Exempt