Clinical Quality Operations, Oncology III
Merck
July 02, 2026
Remote
United States
Operations
Overarching Tasks
- Oversee operational quality execution within the assigned therapeutic area, including operational quality management and inspection management.
- Oversee HQ clinical quality operations and support clinical trial teams; embed quality by design into sponsored trials; ensure vendor oversight; address quality issues.
- Develop quality plans implementing “quality by design” using a risk-based approach.
- Maintain inspection readiness; prepare for, manage, and follow up regulatory inspections.
Operational Quality Management
- Oversee strategic implementation of quality by design principles in assigned clinical trials.
- Develop risk assessment/categorization tools and quality plans with the Clinical Trial Team (CTT).
- Conduct periodic TA-level reviews (e.g., quarterly) of quality plans and risk mitigation approaches to identify trends/signals and provide feedback.
- Facilitate/oversee responses to audit and inspection observations; analyze cross-TA data for signals and implement process improvements.
- Build capabilities to recognize/respond to emerging risks using technology; maintain strong GCP knowledge for digital data management.
- Build stakeholder relationships (incl. research QA) linking Clinical Development, study teams, global business functions, and regional study management.
- Ensure comprehensive oversight of delegated third-party activities.
Inspection Preparation and Management
- Maintain current knowledge of worldwide GCP inspections; monitor/interpret/communicate regulatory developments.
- Coordinate TA oversight, cross-functional inspection readiness, and global inspection tracking (inspections, findings, responses, CAPAs).
- Develop inspection management plans for assigned regulatory inspections.
CAPA Management Support
- Ensure timely implementation of audit/inspection actions; track CAPAs/commitments and verify evidence of completion.
- Maintain complete inspection evidence repositories.
- Guide CCQMs for country-level inspections needing HQ input.
Other Activities
- Provide input to GCP Quality and Compliance Council.
- Strengthen company programs/strategies to increase inspection readiness.
- Lead/support remediation, prevention, process improvement, and training.
Education
- B.A./B.S. or M.A./M.S. in relevant healthcare area (quality or business management preferred).
Prerequisites/Qualifications
- 6+ years in clinical research, including 2+ years developing/managing clinical quality systems and managing regulatory inspections.
- Profound knowledge of clinical development programs, clinical trial processes, and quality management/control tools.
- Expert knowledge of GCP/ICH and worldwide regulatory authority requirements.
- Demonstrated effective CAPA management.
- Experience using risk management tools/processes.
Skills (Required/Preferred)
- Superior international oral/written communication; strong project management/organization.
- Leadership and teamwork; conflict resolution and discretion.
- Lead cross-functional teams; act urgently for inspection matters.
- Analyze/interpret complex problems; strategic/critical/objective thinking with innovation.
- Required skills include: Adaptability, Clinical Quality Management, Clinical Study Design, Clinical Trials Monitoring, Data Analysis, Emerging Risks, GCP, Process Improvement Projects, Regulatory Compliance, Regulatory Inspections, Risk Management, Stakeholder Relationship Management, Strategic Thinking, Training and Development.
- Preferred: Oncology.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Deadline stated on posting.
- Oversee operational quality execution within the assigned therapeutic area, including operational quality management and inspection management.
- Oversee HQ clinical quality operations and support clinical trial teams; embed quality by design into sponsored trials; ensure vendor oversight; address quality issues.
- Develop quality plans implementing “quality by design” using a risk-based approach.
- Maintain inspection readiness; prepare for, manage, and follow up regulatory inspections.
Operational Quality Management
- Oversee strategic implementation of quality by design principles in assigned clinical trials.
- Develop risk assessment/categorization tools and quality plans with the Clinical Trial Team (CTT).
- Conduct periodic TA-level reviews (e.g., quarterly) of quality plans and risk mitigation approaches to identify trends/signals and provide feedback.
- Facilitate/oversee responses to audit and inspection observations; analyze cross-TA data for signals and implement process improvements.
- Build capabilities to recognize/respond to emerging risks using technology; maintain strong GCP knowledge for digital data management.
- Build stakeholder relationships (incl. research QA) linking Clinical Development, study teams, global business functions, and regional study management.
- Ensure comprehensive oversight of delegated third-party activities.
Inspection Preparation and Management
- Maintain current knowledge of worldwide GCP inspections; monitor/interpret/communicate regulatory developments.
- Coordinate TA oversight, cross-functional inspection readiness, and global inspection tracking (inspections, findings, responses, CAPAs).
- Develop inspection management plans for assigned regulatory inspections.
CAPA Management Support
- Ensure timely implementation of audit/inspection actions; track CAPAs/commitments and verify evidence of completion.
- Maintain complete inspection evidence repositories.
- Guide CCQMs for country-level inspections needing HQ input.
Other Activities
- Provide input to GCP Quality and Compliance Council.
- Strengthen company programs/strategies to increase inspection readiness.
- Lead/support remediation, prevention, process improvement, and training.
Education
- B.A./B.S. or M.A./M.S. in relevant healthcare area (quality or business management preferred).
Prerequisites/Qualifications
- 6+ years in clinical research, including 2+ years developing/managing clinical quality systems and managing regulatory inspections.
- Profound knowledge of clinical development programs, clinical trial processes, and quality management/control tools.
- Expert knowledge of GCP/ICH and worldwide regulatory authority requirements.
- Demonstrated effective CAPA management.
- Experience using risk management tools/processes.
Skills (Required/Preferred)
- Superior international oral/written communication; strong project management/organization.
- Leadership and teamwork; conflict resolution and discretion.
- Lead cross-functional teams; act urgently for inspection matters.
- Analyze/interpret complex problems; strategic/critical/objective thinking with innovation.
- Required skills include: Adaptability, Clinical Quality Management, Clinical Study Design, Clinical Trials Monitoring, Data Analysis, Emerging Risks, GCP, Process Improvement Projects, Regulatory Compliance, Regulatory Inspections, Risk Management, Stakeholder Relationship Management, Strategic Thinking, Training and Development.
- Preferred: Oncology.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Deadline stated on posting.