GCP Compliance Manager - Clinical Programs & Trials

Summary

\#LI\-Hybrid

Location: Dublin, Ireland

Other Locations: London, United Kingdom. Please apply to the London advertisement for this location.

This role is based in Dublin, Ireland. Novartis is unable to offer relocation support: please only apply if accessible. Novartis is unable to sponsor Visas for this location

Step into a role where your expertise helps Clinical Trial Teams navigate some of their most complex and high\-risk decisions. As a GCP Compliance Manager – Clinical Programs \& Trials, you will operate as a trusted partner embedded within the clinical trial environment, working across a portfolio of studies to provide expert guidance on Good Clinical Practice and support teams staying in compliance. You will support teams in solving complex scenarios which require careful risk\-assessment —translating technical requirements into clear, actionable insights that enable informed decision\-making.

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 issuesusing 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 supportproactive 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

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.

Read our handbook (PDF 30 MB)

Division
Development
Business Unit
Development
Location
Ireland
Site
Dublin (NOCC)
Company / Legal Entity
IE02 (FCRS \= IE002\) Novartis Ireland Ltd
Functional Area
Research \& Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

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