Overview

The Director of R&D Quality Compliance & Risk Management provides centralized leadership and expertise across R&D Quality functions to drive data-driven proactive compliance and risk management. This role oversees R&D Quality execution of processes for ensuring compliance with global regulations, documentation/communication/mitigation of risks, and reporting/trending of metrics. The Director of R&D Quality Compliance & Risk Management contributes to organizational success through strong individual leadership, collaboration, and fostering a culture of compliance and continuous improvement.

Accountabilities

• Partner cross-functionally to enable transparency and evaluation of R&D Quality risks and issues, collaborating with functional leads to address challenges and constraints. Provide enterprise-wide assessments and risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address risks.
• Lead the implementation and management of an aligned Quality Risk Management program in R&D Quality. Provide assessment, insight, and recommendations on risks across the R&D enterprise to senior R&D Quality management.
• Serve as a key collaborator to R&D Quality personnel on compliance issues, preparation for audits/inspections, regulatory risk assessments, and process improvement opportunities.
• Develop and oversee appropriate R&D Quality metrics reporting on the state of compliance across the R&D enterprise. Identify and drive continuous quality process improvements and risk mitigations through assessment of audit and inspection findings, quality event outcomes, and identification of trends.
• Partner with Global Quality Compliance and Systems as R&D Quality business process owner for the regulatory intelligence process. Ensure robust implementation and execution of the process within R&D Quality to maintain compliance with complex and evolving global regulations.
• Collaborate with R&D Quality leads to coordinate the information flow and consolidation of functional Quality Councils into an enterprise-wide view, extract critical data/issues/risks, and develop an executive-level assessment for review and dissemination by the Senior Director of R&D Quality Compliance, Systems, and Data.
• Support the development and implementation of multi-year organizational strategy for the R&D Quality Compliance, Systems, and Data organization.
• Undertake additional duties as assigned in order to contribute to the overall success of the organization.

Education & Competencies

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

Preferred requirements:

• Advanced degree in Chemistry, Biology, Engineering or related field
• Prior people-management experience

Desired skills & competencies:

• In-depth knowledge of global regulations governing biopharmaceutical research & development as well as the role of Quality Management Systems, with the ability to effectively translate and articulate strategies to ensure compliance.
• Knowledge and understanding of the use of data visualization and analytics to monitor performance, drive improvements, and enable data-driven decision making.
• 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 stakeholders across the enterprise.
• 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, navigate organizational complexities, and influence without authority.

Locations: Boston, MA

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.

U.S. Base Salary Range (Location: Boston, MA): $174,500.00 - $274,230.00

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 job. 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. They 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, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive up to 80 hours of sick time per year, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud of 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.

Locations: Boston, MA | Worker Type: Employee | Worker Sub-Type: Regular | Time Type: Full time

Job Exempt: Yes

Note: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.