GCP Compliance Manager - Clinical Programs & Trials

Summary

\#LI\-Hybrid

For Hybrid working there is an expectation of 12 days per month onsite. This role can also be provided on a Remote working basis, subject to eligibility criteria. Eligibility for remote work can be discussed at interview stage.

Location: Westworks, London, UK

Other Locations: Dublin, Ireland. Please apply to the Dublin advertisement for this location

This role is based in London, UK. 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 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

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
United Kingdom
Site
London (The Westworks)
Company / Legal Entity
GB16 (FCRS \= GB016\) Novartis Pharmaceuticals UK Ltd.
Alternative Location 1
Dublin (NOCC), Ireland
Functional Area
Research \& Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

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