Vendor Operations Lead Global Clinical Operations (GCO)
Job Summary
Salary Range:
75880.00 - 140920.00Job Description Summary
Location: Dublin IrelandRelocation 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 were committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: 75880.00 - 140920.00 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 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:
Commitment to Diversity and Inclusion / EEO
Novartis is committed to building an outstanding inclusive work environment and diverseteamsrepresentative 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 QualityRequired Experience:
Manager
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.