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Global Quality Risk Manager
2 weeks ago
The Senior Risk Governance Specialist is a strategic role that oversees the implementation and continuous improvement of risk-based quality management practices at trial level.
This position works within a matrix environment, accountable for comprehensive clinical quality (GCP) risk governance across assigned trials and programs.
- Key Responsibilities:
- • Facilitate trial protocol risk assessment across multiple cross-functional domains associated with critical-to-quality (CtQ) data and processes.
- • Responsible for drafting, maintaining, and archiving study-specific documentation of risk management activities.
- • Partner with the RBQM system configuration team to ensure risk indicators are programmed and functioning per operational requirements.
- • Conduct periodic central surveillance of aggregate data at the study and program level, leveraging available analytics/visualizations in the RBQM system.
- • Facilitate risk review meetings and discussions with study and program team members to effectively communicate findings.
- Additional Responsibilities:
- • Support internal and external audits and inspections.
- • Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.
- • Identify and share lessons learned, best practices, successes, case studies, failures, and process improvement opportunities.
- • Act as a change agent, champion, subject matter expert, and point of contact for RBQM methodology.
Requirements:
- Education:
- • Bachelor's Degree in a health-related or life science area.
- Experience:
- • Minimum 4 years of experience in the pharmaceutical or CRO industry.
- • Preferred minimum 1 year of experience in Risk-Based Quality Management.
Desirable Skills:
- • Robust understanding of the drug development process and clinical trial execution.
- • Knowledge of industry regulatory standards.
- • Experience in risk management, sponsor audits, and health authority inspections.
- • Demonstrated ability to analyze data and make recommendations for improvement.
