Associate Director Clinical Program Quality
Takeda
6 months ago
Remote
United States
$137,000 - $215,270 USD yearly
Clinical Research and Development
Associate Director, Clinical Program Quality
How you will contribute:
- Provide quality assurance oversight for global clinical research programs to ensure ongoing inspection readiness.
- Serve as a strategic quality partner to Clinical Program Teams and key stakeholders, offering risk-based GCP quality and compliance advice.
- Define and implement program-specific, risk-based audit and compliance strategies across studies, sites, vendors, documents, databases, and internal systems.
- Lead pre-approval and health authority inspection readiness; manage inspections; coordinate responses, follow-up actions, and risk mitigation.
- Lead investigations into major quality issues, serious GCP breaches, and scientific misconduct, including root cause analysis and CAPA development.
- Monitor, analyze, and present quality and compliance metrics; escalate critical or systemic risks to management and recommend corrective actions.
- Support organizational quality excellence through mentoring, cross-functional collaboration, due diligence, and process improvement initiatives.
Reporting line:
- Head of Clinical Program Quality, Gastrointestinal and Inflammation.
What you bring:
- Bachelor’s degree required.
- At least 10 years of experience in the pharmaceutical, biotechnology, or related healthcare industry.
- At least 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
- Strong knowledge of ICH GCP and applicable global clinical development regulations and guidance.
- Advanced expertise in planning, conducting, and reporting audits; translating findings into corrective action plans.
- Excellent communication, stakeholder management, negotiation, and influencing skills in a matrix environment.
- Strong judgment, project management, critical thinking, and analytical skills; ability to manage complex issues and multiple priorities.
How you will contribute:
- Provide quality assurance oversight for global clinical research programs to ensure ongoing inspection readiness.
- Serve as a strategic quality partner to Clinical Program Teams and key stakeholders, offering risk-based GCP quality and compliance advice.
- Define and implement program-specific, risk-based audit and compliance strategies across studies, sites, vendors, documents, databases, and internal systems.
- Lead pre-approval and health authority inspection readiness; manage inspections; coordinate responses, follow-up actions, and risk mitigation.
- Lead investigations into major quality issues, serious GCP breaches, and scientific misconduct, including root cause analysis and CAPA development.
- Monitor, analyze, and present quality and compliance metrics; escalate critical or systemic risks to management and recommend corrective actions.
- Support organizational quality excellence through mentoring, cross-functional collaboration, due diligence, and process improvement initiatives.
Reporting line:
- Head of Clinical Program Quality, Gastrointestinal and Inflammation.
What you bring:
- Bachelor’s degree required.
- At least 10 years of experience in the pharmaceutical, biotechnology, or related healthcare industry.
- At least 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
- Strong knowledge of ICH GCP and applicable global clinical development regulations and guidance.
- Advanced expertise in planning, conducting, and reporting audits; translating findings into corrective action plans.
- Excellent communication, stakeholder management, negotiation, and influencing skills in a matrix environment.
- Strong judgment, project management, critical thinking, and analytical skills; ability to manage complex issues and multiple priorities.