Director, Clinical Program Quality and Excellence
Boston, Massachusetts Job ID R0183579 Category Quality Subcategory Quality Business Unit Research & Development Job Type Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role
The Director, Clinical Program Quality & Excellence (CPQE) serves as a strategic quality leader supporting Takeda’s clinical development portfolio. This role is responsible for shaping and executing risk-based quality management strategies across assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle.
You will partner closely with global cross-functional stakeholders, including Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality organizations, to identify emerging risks, drive issue resolution, and strengthen quality performance across clinical programs. This position plays a critical role in supporting portfolio decision-making, safeguarding patient safety, ensuring data integrity, and enabling successful regulatory submissions worldwide.
How you will contribute
Lead quality management activities for assigned clinical development programs, implementing proactive and risk-based quality oversight strategies
Serve as a strategic quality advisor to asset-level governance bodies, including Global Program Teams, Clinical Sub-Teams, and Clinical Review Boards
Drive identification, escalation, and mitigation of quality risks and critical issues to support informed, patient-centric decision-making
Lead investigations into significant quality events, including GCP Serious Breaches, scientific misconduct, and major compliance deviations
Develop and execute inspection readiness strategies, ensuring sustainable compliance throughout clinical trial execution
Lead global GCP inspection planning and preparation activities, serving as a subject matter expert during regulatory interactions and inspections
Design and implement risk-based audit strategies to proactively identify and mitigate quality and compliance risks
Partner with Study Execution Teams to strengthen quality oversight models and embed real-time inspection readiness practices
Mentor and support Clinical Program Quality professionals, fostering a culture of accountability, quality by design, and continuous improvement
Drive cross-functional issue resolution and promote adoption of best practices across clinical development programs
Contribute to R&D Quality continuous improvement initiatives by sharing lessons learned, inspection insights, and quality trends across the organization
Influence senior stakeholders to strengthen compliance, improve operational effectiveness, and protect patient safety and data integrity
What you bring to Takeda
Required Qualifications
Bachelor's degree in a scientific, medical, healthcare, or related discipline required
Minimum 10 years of experience within the pharmaceutical, biotechnology, or healthcare industry
At least 5 years of experience in Quality, Compliance, Clinical Development Quality, or related functions
Deep knowledge of Good Clinical Practice (GCP) regulations, quality systems, and clinical trial processes
Experience supporting global clinical development programs from study start-up through regulatory submission
Demonstrated experience leading quality oversight, inspection readiness, audit programs, and compliance initiatives
Strong investigation and root cause analysis experience related to quality events and compliance issues
Proven ability to influence and partner effectively with senior leaders and cross-functional stakeholders
Excellent communication, leadership, and organizational skills
Preferred Qualifications
Advanced scientific or healthcare degree (MS, PharmD, PhD, MD, or equivalent)
Experience supporting regulatory inspections and health authority interactions
Experience in clinical portfolio governance and risk management
Background in global clinical operations, pharmacovigilance, or quality systems
Experience leading complex remediation programs and continuous improvement initiatives
Strong understanding of quality-by-design principles and risk-based quality management approaches
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
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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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, MAU.S. Base Salary Range:
$177,000.00 - $278,080.00
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.
Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob 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.
