Global Vendor Compliance & Inspection Lead

IE02 (FCRS = IE002) Novartis Ireland Ltd; Dublin; Hybrid; EUR 76,000 - 141,000; Full time

Benefits offered by this job

Performance-based bonus

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Parental leave

Job summary

Novartis Ireland Ltd. is seeking a Vendor Operations Lead for Global Clinical Operations (GCO) to strengthen processes for regulatory inspections and audits.

You will provide SME expertise across inspection readiness, CAPA, vendor compliance, and quality improvement, collaborating with global teams and external partners to ensure adherence to Novartis standards. The role focuses on risk-based improvements, governance, and training to drive vendor performance and readiness within a regulated

Qualifications

• University degree in business or a relevant field, or equivalent professional experience.
• Typically 8–10+ years’ experience in clinical operations, including systems, regulatory requirements, and vendor management.
• Strong knowledge of Good Clinical Practice and regulations (GCP, GxP and ICH).
• Experience supporting regulatory inspections and managing inspection back-room activities.
• Experience with inspection readiness, storyboards, evidence collection, and regulatory document requests.
• Experience supporting audits and developing and managing CAPAs.
• Understanding of clinical trial design, vendor compliance, and third-party requirements.
• Proven global matrix leadership with independent ownership and diplomatic influence.

Responsibilities

• Drive development and implementation of vendor operations standards, processes, and governance frameworks.
• Lead inspection readiness and support regulatory inspection activities across vendor partnerships and operations.
• Ensure consistent implementation of vendor risk assessment, selection, and compliance processes.
• Oversee vendor quality and compliance metrics, identifying trends, risks, and improvement opportunities.
• Develop and maintain templates, tools, and operational resources supporting vendor governance and compliance.
• Support audit planning, preparation, and follow-up, including corrective and preventive action management.
• Act as a subject‑matter expert on vendor compliance, inspection readiness, and quality management practices.
• Partner with global and local stakeholders to strengthen operational consistency and regulatory compliance.
• Drive continuous improvement initiatives that enhance vendor performance, quality outcomes, and inspection readiness.
• Deliver training and communications supporting adoption of systems, processes, and compliance requirements.

Skills

Regulatory compliance

Inspection readiness

Vendor management

GxP knowledge

Cross-functional collaboration

Analytical decision-making

Diplomatic stakeholder influence

Education

University degree in business or relevant field

Tools

Audit planning tools

Job description

Novartis Ireland Ltd. is seeking a Vendor Operations Lead for Global Clinical Operations (GCO) to strengthen processes for regulatory inspections and audits.

You will provide SME expertise across inspection readiness, CAPA, vendor compliance, and quality improvement, collaborating with global teams and external partners to ensure adherence to Novartis standards. The role focuses on risk-based improvements, governance, and training to drive vendor performance and readiness within a regulated