Dublin (NOCC), Ireland
Onsite
Salary Range:
€75,880.00 - €140,920.00
Job Description Summary
#LI-Hybrid
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.
Key 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 experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering:
https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
Commitment to Diversity and Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Skills Desired
Budget Management, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Health Sciences, Lifesciences, People Management, Regulatory ComplianceWant to know if this job is worth applying to?