GCP Compliance Manager – Global Clinical Operations
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: London • 🇬🇧 United Kingdom
Visit company websiteJob Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Accountability for the GCP compliance oversight and control of regulated GCO activities
- Provide GxP expertise and support to other functions
- Management of GCO wide systemic quality issues
- Coordinate GCO audits and inspections landscape
- Contribute to the GCO self-assessment strategy
- Collaborate with relevant functions across GCO and the wider organization
- Monitor relevant indicators and metrics to ensure the detection of unreported issues
Requirements
- 8+ years industry experience specifically in clinical operations
- Advanced knowledge of clinical research international standards and regulatory requirements from Health Authorities
- Audits and inspections experience highly desirable
- Organizational and analytical skills associated with quality management and continuous improvement
- Critical thinking ability and risk management mindset
- Strong skills to facilitate/optimize contribution of team members as individuals and as a cohesive team
- Ability to work effectively in a matrix cross-functional environment
- Strong capacity for working independently with minimal guidance
- Strong written and verbal communication skills
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCP complianceGxP expertisequality managementauditsinspectionsclinical research standardsregulatory requirementsrisk managementcontinuous improvementdata analysis
Soft skills
organizational skillsanalytical skillscritical thinkingteam facilitationcollaborationindependencecommunication skillsmatrix environment adaptabilityproblem-solvingleadership