Director, R&D Quality Process Operations

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Job Description

The Director of R&D Quality Process Operations provides centralized leadership and expertise across R&D Quality functions to drive the operationalization and oversight of key Global Quality processes.

This role is responsible for oversight of several key processes in R&D Quality and partners with RDQ functional leads for successful execution. The Director of R&D Quality Process Operations contributes to organizational success through strong individual leadership, collaboration, and fostering a culture of compliance and continuous improvement.

Accountabilities:

• Ensure R&D Quality oversight/compliance processes (e.g., supplier quality, incident management, due diligence) are robust and align with Global Quality (GQ) processes and applicable regulatory requirements.

• Lead organizational analysis and review of external supplier compliance/quality performance, consolidating data from across the R&D Quality functions to present a holistic data-driven view of risks and areas of heightened focus. Ensure compliant and timely conduct of audits, reporting, and follow-up per global and local procedures.

• Oversee R&D Quality incident escalation and management process, deliver clear and concise information to senior management and partner with stakeholders where needed to ensure robust investigations, resolution of quality issues, and implementation of effective CAPAs.

• Serve as primary liaison to Global Quality for due diligence/acquisition/divestment GxP activities. Coordinate the assignment of R&D Quality functional SMEs for assessments/activities. Lead R&D Quality post-acquisition compliance assessment activities.

• Serve as R&D Quality lead to ensure oversight and compliance with Takeda records management requirements across the organization.

• Partner with Global Quality Compliance and Systems to align on strategies for revisions to global processes, represent R&D Quality interests, and ensure connectivity of R&D Quality SMEs to GQ workstreams where needed.

• Partner with R&D Quality leaders and functions lead change management strategies and support the evolution of new ways of working, in alignment with desired organizational goals.

• 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.

Job Description
Education & Competencies (Technical and Behavioral): List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.

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

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

• Desired skills & competencies
o 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.
o Knowledge and understanding of the use of data visualization and analytics to monitor performance, drive improvements, and enable data-driven decision making.
o Proven leadership, collaboration, and influencing skills, coupled with a demonstrated ability to solve problems and drive impactful change.
o Proficiency in working with diverse individuals across all organizational levels.
o Exceptional interpersonal, verbal, and written communication skills, enabling successful interaction with stakeholders across the enterprise.
o Adaptability and flexibility to thrive in dynamic environments, along with the ability to manage and deliver multiple projects on time.
o Strong attention to detail and organizational expertise, with a capacity to work independently across global settings, navigate organizational complexities, and influence without authority.

#GMSGQ #LI-MA1 #ZR1

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:

Boston, MA

U.S. Base Salary Range:

$174, $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. 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.

LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Job Exempt

YesIt 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.

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