Novartis
Pharmaceutical
GCPComplianceManagerClinicalPrograms&Trials
“GCP Compliance Manager - Clinical Programs & Trials at Novartis. Skills: GCP Compliance, Clinical Trials, Regulatory Requirements, Risk Management. Provide compliance oversight. Act as primary compliance partner”
Industry & Context.
Investigate complex issues; Root cause analysis; Develop corrective actions; Problem-solving mindset; Navigate ambiguity; Navigate regulatory trade-offs
12 days per month onsite, Subject to eligibility criteria for remote
What They're Looking For.
Must Have
Advanced degree in science, Significant experience in clinical operations, Significant experience in clinical trial management, Knowledge of Good Clinical Practice standards, Knowledge of global regulatory requirements, Ability to investigate complex issues, Ability to perform root cause analysis, Ability to develop effective corrective actions, Ability to translate technical compliance concepts, Ability to work independently, Ability to manage multiple trials, Ability to prioritise across competing demands
Nice to Have
Experience supporting audits, Experience supporting inspections, Experience with health authority inspections, Openness to adopting AI, Openness to experimenting with new technologies
What You'll Do.
Provide compliance oversight
Act as primary compliance partner
Enable decision-making on complex scenarios
Lead cross-functional discussions
Lead resolution of quality issues
Perform structured investigation
Perform root cause analysis
Translate complex regulatory requirements
Coordinate inspection readiness activities
Manage subsequent CAPA
Monitor key indicators
Support proactive mitigation strategies
Deliver self-assessment checks
Share insights to strengthen compliance
Share insights for continuous improvement
Collaborate across functions
Ensure aligned compliance practices
Ensure effective compliance practices
Support quality assessments
Enable informed decision-making
Enable risk-based decision-making
Champion a culture of quality
Champion data integrity
Champion accountability
How You'll Work.
Team & Collaboration
Study leaders; Vendor managers; Cross-functional stakeholders; Quality Assurance; Development; Global Clinical Operations
Communication Scope
Translate technical concepts; Practical guidance
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