New · posted Oct 20
Takeda · Pharmaceuticals
Director, Clinical Program Quality and Excellence
- Boston, MA
- On-site
- Full-time
- Director
Open until filled
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
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.
What you need
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 Qualificationsnice to have
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
Pay
$177,000 – $278,080 a year
Employer providedTakeda 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
$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.
For information about our benefits, please click here.
Where you'll work
Boston, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Boston, MAWorking conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Boston, MA
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.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
By 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.
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.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Clinical Quality & Safety roles at this level.
This roleEmployer provided
Director roles in Massachusetts11 roles publishing pay
Director roles in the US21 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $177,000 | — | $278,080 |
| Massachusetts (middle half) | $199,750 | $227,500 | $229,000 |
| All US (middle half) | $201,000 | $227,500 | $244,500 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Clinical Quality & Safety roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Quality & Safety
The general path across 36 open Clinical Quality & Safety roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance13
- Collaboration and leadership13
- Quality systems and risk6
- Regulatory submissions3
- Investigations and CAPA2
- Data and digital systems2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Takeda on Regulatory Jobs
- 43
- Open roles
- 41
- Distinct roles
- 16
- Locations
By discipline
- Regulatory19 44%
- Quality17 40%
- Compliance & Safety6 14%
By level
- Director23 53%
- Senior & Principal11 26%
- Manager5 12%
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Director, Clinical Program Quality and Excellence at Takeda
Open until filled. $177K–$278K a year, employer provided.