Vendor Operations Lead - Global Clinical Operations (GCO)

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

Salary Range: €75,880.00 - €140,920.00 Job Description Summary Location: Dublin, Ireland Relocation Support: This role is based in Dublin, Ireland. Novartis is unable to offer relocation support: please only apply if accessible. Strong vendor Quality and Compliance are critical to successful clinical development and inspection readiness. As Vendor Operations Lead - Global Clinical Operations (GCO), you will lead and strengthen the processes that prepare our vendor organization for regulatory inspections and audits. You will provide subject-matter expertise across inspection readiness, audit support, corrective and preventive actions, vendor compliance, and quality improvement, while helping colleagues respond effectively in demanding regulatory environments. Working across global functions and external partnerships, you will use compliance insights and performance trends to identify risks, improve processes, and ensure vendor activities meet Novartis standards and regulatory expectations.

Job Description Key Responsibilities

• Drive the 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.

Essential Requirements

• 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 third-party/vendor management.
• Strong knowledge of Good Clinical Practice and regulations (GCP, GxP and ICH).
• Demonstrated experience supporting and leading regulatory inspections and managing inspection back-room activities.
• Experience with inspection readiness, storyboards, evidence collection, and regulatory document request management.
• Experience supporting corporate or supplier audits and developing and managing corrective and preventive actions.
• Strong understanding of clinical trial design, vendor compliance, and third-party requirements across clinical operations.
• Proven global matrix leadership, including independent ownership, analytical decision‑making, and diplomatic stakeholder influence.

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 Euro Annual 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.
• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs
• flexible and hybrid working options, where possible
• 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

• Good Clinical Practice (GCP)
• GxP Compliance
• GxP Regulations
• Inspection Readiness
• Process Improvements
• Quality Management
• Regulatory Compliance
• Regulatory Inspections
• Regulatory Requirements
• Vendor Compliance
• Vendor Partnerships
• Vendor Performance Management
• Vendor Quality

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.