Director, Clinical Risk Management Post Approval Delivery Unit
GB006 High Wycombe, United Kingdom
GBP 83K-112K (estimate) Executive-level Full Time
Tasks
- Advise CAPA plan development and effectiveness checks
- Communicate quality risks and mitigations
- Coordinate identification assessment mitigation of quality risks
- Coordinate quality integration in post licensing and acquisition
- Develop risk mitigation plans
- Ensure inspection readiness
- Escalate significant quality issues
- Establish quality risk assessment process
- Evaluate serious breaches
- Interpret issues requiring quality investigations
- Lead clinical risk management
- Lead inspection processes and inspection tools
- Lead quality risk monitoring reviews
- Provide regulatory compliance consultancy
- Provide remote inspection support
- Provide risk based trial and program oversight
- Provide strategic guidance on quality risk assessments
- Support sponsor monitor inspections
- Support third party inspections
Perks/Benefits
Skills/Tech-stack
CAPA | Clinical Quality Plan | Clinical quality | Clinical trials | Compliance Management | Data Visualization | Data analytics | GCP | GLP | GMP | GPvP | ICH | Management System | Microsoft Office | Quality Assurance | Quality Management System | Quality Plan | Quality Risk Management | Quality management | Risk Assessment | Risk Management | S&OP | Spotfire | Tableau
Education
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