GCP Compliance Manager - Clinical Programs & Trials
About the Role
Acting as a key point of contact across study leaders, vendor managers, and cross-functional stakeholders, you will enable issue resolution, strengthen inspection readiness, and ensure trials are delivered to the highest standards of quality and compliance. This is a role for a curious, solutions-oriented professional who thrives on investigation, collaboration, and influencing outcomes in a fast-paced, global clinical landscape.
Key Responsibilities
- Provide compliance oversight for clinical programs and trials, ensuring adherence to Good Clinical Practice standards
- Act as primary compliance partner to Clinical Trial Teams, enabling decision-making on complex regulatory scenarios
- Lead cross-functional discussions and resolution of quality issues using structured investigation and root cause analysis
- Translate complex regulatory requirements into clear, actionable guidance for cross-functional clinical stakeholders
- Coordinate inspection readiness activities, including preparation and inspection management, in addition to subsequent CAPA management
- Monitor key indicators and trends to portfolio issues detect early signals, and support proactive mitigation strategies
- Deliver self-assessment checks and controls, sharing insights to strengthen compliance and continuous improvement
- Collaborate across functions, including Quality Assurance and Development, to ensure aligned and effective compliance practices
- Support quality assessments of programs and trials and enable informed, risk-based decision-making
- Champion a strong culture of quality, data integrity, and accountability across Global Clinical Operations and beyond
Essential Requirements
- Advanced degree in science, engineering, or related discipline
- Significant experience in clinical operations and clinical trial management within a pharmaceutical or healthcare environment
- Strong knowledge of Good Clinical Practice standards and global regulatory requirements
- Proven ability to investigate complex issues, perform root cause analysis, and develop effective corrective actions
- Excellent communication skills with ability to translate technical compliance concepts into clear, practical guidance
- Strong problem-solving mindset with curiosity and ability to navigate ambiguity and regulatory trade-offs
- Demonstrated ability to work effectively in cross-functional, matrixed teams and influence diverse stakeholders
- Ability to work independently, manage multiple trials simultaneously, and prioritise across competing demands
Desirable Requirements
- Experience supporting audits and inspections, including preparation and interaction with health authority inspections
- Openness to adopting and experimenting with artificial intelligence and new technologies to optimize ways of working
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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