Director, Clinical Program Quality & Excellence (CPQE), TAU
Takeda
August 20, 2026
On-site
Cambridge, MA
$177,000 - $278,080 USD yearly
Clinical Research and Development
About the Role:
As Director, Clinical Program Quality & Excellence (CPQE), TAU, you will provide strategic quality leadership across clinical assets, driving a risk-based quality management approach that enhances program performance, strengthens regulatory confidence, and supports faster delivery of innovative therapies to patients.
How You Will Contribute:
- Lead quality management for assigned asset-level clinical programs, developing and implementing proactive, risk-based quality strategies
- Provide strategic oversight of quality risks/issues/mitigation plans; escalate key insights to governance bodies
- Direct investigations into Serious Breaches (GCP), Scientific Misconduct, and other significant quality events using robust root cause analysis
- Drive inspection readiness across assigned clinical programs throughout the clinical trial lifecycle
- Shape and execute global GCP inspection strategies; prepare for submission-related inspections and serve as a subject matter expert
- Develop and implement risk-based audit strategies to identify concerns early and proactively mitigate risks
- Mentor and support CPQ team members aligned to Study Execution Teams (SETs)
- Foster cross-functional collaboration to resolve quality events and drive continuous improvement
- Contribute to R&D Quality continuous improvement initiatives for Clinical Trial Delivery and PV Systems
Skills and Qualifications:
- Scientific or allied health/medical degree (BSc required; MSc or PhD preferred)
- Minimum 10 years’ experience in the global pharmaceutical industry, including at least 5 years in Quality and/or Compliance supporting clinical development
- Advanced expertise across the clinical development lifecycle with hands-on GCP knowledge
- Experience in quality leadership roles (quality systems oversight, clinical portfolio governance, audit programs, global regulatory inspection management, investigations/remediation)
Application Instructions:
By clicking the “Apply” button, I understand the employment application process will commence.
As Director, Clinical Program Quality & Excellence (CPQE), TAU, you will provide strategic quality leadership across clinical assets, driving a risk-based quality management approach that enhances program performance, strengthens regulatory confidence, and supports faster delivery of innovative therapies to patients.
How You Will Contribute:
- Lead quality management for assigned asset-level clinical programs, developing and implementing proactive, risk-based quality strategies
- Provide strategic oversight of quality risks/issues/mitigation plans; escalate key insights to governance bodies
- Direct investigations into Serious Breaches (GCP), Scientific Misconduct, and other significant quality events using robust root cause analysis
- Drive inspection readiness across assigned clinical programs throughout the clinical trial lifecycle
- Shape and execute global GCP inspection strategies; prepare for submission-related inspections and serve as a subject matter expert
- Develop and implement risk-based audit strategies to identify concerns early and proactively mitigate risks
- Mentor and support CPQ team members aligned to Study Execution Teams (SETs)
- Foster cross-functional collaboration to resolve quality events and drive continuous improvement
- Contribute to R&D Quality continuous improvement initiatives for Clinical Trial Delivery and PV Systems
Skills and Qualifications:
- Scientific or allied health/medical degree (BSc required; MSc or PhD preferred)
- Minimum 10 years’ experience in the global pharmaceutical industry, including at least 5 years in Quality and/or Compliance supporting clinical development
- Advanced expertise across the clinical development lifecycle with hands-on GCP knowledge
- Experience in quality leadership roles (quality systems oversight, clinical portfolio governance, audit programs, global regulatory inspection management, investigations/remediation)
Application Instructions:
By clicking the “Apply” button, I understand the employment application process will commence.