Director, Clinical Program Quality and Excellence

Takeda Pharmaceutical Co.; United States; On-site; USD 177,000 - 278,000; Full time

Job summary

The Director, Clinical Program Quality & Excellence (CPQE) at Takeda leads risk-based quality management across the clinical development portfolio, ensuring inspection readiness, data integrity, and regulatory compliance throughout trials. The role partners with global Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality to reinforce patient safety and drive continuous improvement.

Responsibilities include leading quality oversight, investigations of major quality events,

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.
• Proven ability to influence and partner effectively with senior leaders and cross-functional stakeholders.
• Excellent communication, leadership, and organizational skills.

Responsibilities

• 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

Education

Bachelor's degree in a scientific, medical, healthcare, or related discipline

Advanced scientific or healthcare degree

Job description

Job Description

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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives - including your own.

Takeda is an equal opportunity employer.

Takeda Compensation and Benefits Summary

Location: Boston, MA U.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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular Time Type Full time

Job Exempt

Yes

Legal

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.

Contact

Takeda is an equal opportunity employer.