Vendor Operations Lead - Global Clinical Operations (GCO)

Novartis Ireland; Dublin; On-site; EUR 76,000 - 141,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible/hybrid work

14 weeks parental leave

Job summary

Novartis Ireland in Dublin seeks a Vendor Operations Lead to strengthen processes for regulatory inspections and audits within Global Clinical Operations (GCO).

You will provide subject-matter expertise across inspection readiness, CAPA, vendor compliance and quality improvement, partnering with global functions to ensure adherence to Novartis standards and regulatory expectations.

Qualifications

• Knowledge of GCP, GxP and ICH regulations and their application in clinical operations.
• Experience supporting regulatory inspections and management of inspection back-room activities.
• Experience with corrective and preventive actions and vendor compliance programs.

Responsibilities

• Lead development and implementation of vendor operations standards and governance.
• Drive inspection readiness and support regulatory inspection activities across vendor partnerships.
• Ensure vendor risk assessment, selection, and compliance processes are consistently applied.
• Oversee vendor quality metrics, identify trends and opportunities for improvement.
• Develop templates, tools and resources for vendor governance and compliance.
• Support audit planning, preparation and follow-up, including CAPA management.
• Act as SME on vendor compliance, inspection readiness and quality management practices.
• Partner with global and local stakeholders to strengthen regulatory compliance.
• Drive continuous improvement to vendor performance and inspection readiness.
• Deliver training and communications supporting system/process adoption.

Skills

GCP knowledge

Vendor management

Inspection readiness

Regulatory compliance

Audit support

Education

University degree in business or relevant field

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.

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.
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.

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)