Director, Clinical Program Quality and Excellence
Takeda
August 15, 2026
Remote friendly (Boston, MA)
United States
$177,000 - $278,080 USD yearly
Clinical Research and Development
About the role
The Director, Clinical Program Quality & Excellence (CPQE) shapes and executes risk-based quality management strategies across assigned clinical programs to ensure inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle.
Responsibilities
- Lead quality management for assigned clinical development programs using proactive, risk-based quality oversight
- Advise asset-level governance bodies (Global Program Teams, Clinical Sub-Teams, Clinical Review Boards)
- Identify, escalate, and mitigate quality risks and critical issues for patient-centric decision-making
- Lead investigations into significant quality events (e.g., GCP Serious Breaches, scientific misconduct, major compliance deviations)
- Develop and execute inspection readiness strategies and lead global GCP inspection planning/preparation
- Design and implement risk-based audit strategies
- Partner with Study Execution Teams to strengthen quality oversight models and embed real-time inspection readiness
- Mentor Clinical Program Quality professionals; promote quality by design and continuous improvement
- Drive cross-functional issue resolution and adoption of best practices
- Contribute to R&D Quality continuous improvement by sharing lessons learned and quality trends
Qualifications
Required:
- Bachelor’s degree in a scientific/medical/healthcare or related discipline
- 10+ years in pharma/biotech/healthcare
- 5+ years in Quality, Compliance, Clinical Development Quality, or related functions
- Deep knowledge of GCP, quality systems, and clinical trial processes
- Experience supporting global clinical development (start-up through regulatory submission)
- Experience leading inspection readiness, audit programs, and compliance initiatives
- Strong investigation and root cause analysis experience
- Ability to influence senior leaders and cross-functional stakeholders
- Excellent communication, leadership, and organizational skills
Preferred:
- Advanced degree (MS, PharmD, PhD, MD, or equivalent)
- Experience with 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 remediation programs and continuous improvement
- Strong understanding of quality-by-design and risk-based quality management
The Director, Clinical Program Quality & Excellence (CPQE) shapes and executes risk-based quality management strategies across assigned clinical programs to ensure inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle.
Responsibilities
- Lead quality management for assigned clinical development programs using proactive, risk-based quality oversight
- Advise asset-level governance bodies (Global Program Teams, Clinical Sub-Teams, Clinical Review Boards)
- Identify, escalate, and mitigate quality risks and critical issues for patient-centric decision-making
- Lead investigations into significant quality events (e.g., GCP Serious Breaches, scientific misconduct, major compliance deviations)
- Develop and execute inspection readiness strategies and lead global GCP inspection planning/preparation
- Design and implement risk-based audit strategies
- Partner with Study Execution Teams to strengthen quality oversight models and embed real-time inspection readiness
- Mentor Clinical Program Quality professionals; promote quality by design and continuous improvement
- Drive cross-functional issue resolution and adoption of best practices
- Contribute to R&D Quality continuous improvement by sharing lessons learned and quality trends
Qualifications
Required:
- Bachelor’s degree in a scientific/medical/healthcare or related discipline
- 10+ years in pharma/biotech/healthcare
- 5+ years in Quality, Compliance, Clinical Development Quality, or related functions
- Deep knowledge of GCP, quality systems, and clinical trial processes
- Experience supporting global clinical development (start-up through regulatory submission)
- Experience leading inspection readiness, audit programs, and compliance initiatives
- Strong investigation and root cause analysis experience
- Ability to influence senior leaders and cross-functional stakeholders
- Excellent communication, leadership, and organizational skills
Preferred:
- Advanced degree (MS, PharmD, PhD, MD, or equivalent)
- Experience with 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 remediation programs and continuous improvement
- Strong understanding of quality-by-design and risk-based quality management