GCP Compliance Manager - Global Clinical Operations

About the role

Step into a role where your judgment, curiosity, and clinical operations expertise can directly influence quality, compliance, and ultimately patient impact across a global portfolio. As GCP Compliance Manager - Global Clinical Operations, you will work at the heart of the clinical trial engine, leading complex quality issue management, supporting large-scale system audits and inspection readiness, and helping teams navigate high-stakes decisions with clarity and confidence. This is an opportunity for a proactive, agile professional who thrives in the grey zone-someone who can bring structure to complexity, coordinate diverse stakeholders across functions, and translate regulatory and operational risk into clear, actionable direction in a fast-moving global environment. Job Description The GCP Compliance Manager (GCO) ensures risk‑based oversight and controls of regulated GCO activities, prioritizing patient safety, data integrity, and regulatory compliance. This role drives the three core pillars of GCP Compliance: Quality Issue Management, System/process Audits & Global Health Authority Inspections (incl. inspection readiness), and Self‑Assessment execution. GCP Compliance Manager (GCO) ensures timely identification, escalation, and resolution of systemic issues to maintain continuous compliance and provides expert GxP guidance and partners cross‑functionally to ensure adherence to ICH‑GCP and regulatory requirements. You will hold responsibility for fostering and driving a strong compliance culture, actively contributing to governance boards and promoting the highest standards of ethics and integrity.

Responsibilities

• Provide compliance oversight for regulated Global Clinical Operations activities, ensuring adherence to Good Clinical Practice standards
• Lead management of complex, portfolio-wide quality issues, ensuring timely resolution and effective corrective and preventive actions
• Oversee the global audits and inspections landscape, coordinating system and process audits and supporting inspection readiness activities
• Support global inspections by enabling stakeholder preparation, coordinating responses, and ensuring readiness for health authority interactions
• Deliver Global Clinical Operations self-assessment checks and controls, sharing insights to strengthen compliance and continuous improvement
• Coordinate cross-functional risk assessments, enabling proactive identification, evaluation, and mitigation of portfolio-level risks
• Drive structured investigation activities, including root cause analysis and development of sustainable corrective and preventive actions
• Establish clear frameworks for quality issue management, ensuring consistent communication, documentation, and decision-making
• Partner with Clinical Trial Teams and functional experts to minimize disruption while maintaining compliance and quality standards
• Influence and align diverse stakeholders across Global Clinical Operations and beyond, leading through complexity and driving accountability
• Essential Requirements
• Advanced degree in Life Sciences, Engineering, or related discipline; advanced qualification such as Masters or Doctorate preferred
• Significant clinical operations experience, ideally 8+ years, within pharmaceutical or contract research organizations across global trials
• Strong knowledge of Good Clinical Practice and global regulatory requirements from health authorities
• Proven experience managing quality issues, investigations, and corrective and preventive actions in complex environments
• Experience supporting audits, inspections, and inspection readiness activities within clinical development programs
• Ability to operate across a portfolio, coordinating multiple studies, stakeholders, and complex compliance scenarios
• Strong analytical and critical thinking skills, with ability to structure information and drive risk-based decision making
• Excellent communication and influencing skills, with ability to lead without authority in cross-functional environments under pressure
• Desirable Requirements
• Experience with system and process audits, including end-to-end or cross-functional audit scopes
• Familiarity with computerized system validation, data processes, or broader digital and technology-enabled clinical environments
• Benefits & Rewards
• At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.
• Expected Annual Base Salary Range for role: € 75,880.00 - 140,920.00 EUR
• The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experien

Benefits

Additional Information

Salary Range: €75,880.00 - €140,920.00 Job Description Summary #LI-Hybrid The location for this position is Dublin, Ireland. The role is also available in London, UK. Please apply to relevant job posting for this location. Relocation Support: This role is based in Dublin, Ireland. Novartis is unable to offer relocation support: please only apply if accessible.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Novartis? Share your experience