Vendor Operations Lead - Global Clinical Operations (GCO)

Novartis; Barcelona; Híbrido; EUR 64.000 - 118.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

On-site 12 days/month

Descripción de la vacante

Novartis in Barcelona seeks a senior vendor governance and compliance leader to drive standards across vendor operations, lead inspection readiness, and ensure regulatory compliance.

You will collaborate with global and local stakeholders, develop templates and tools, support audits, and manage corrective actions and documentation requests.

The role requires 8–10+ years in clinical operations, strong knowledge of GCP, GxP and ICH, and a proven track record in vendor management.

Formación

• University degree or equivalent experience in a relevant field.
• 8–10+ years in clinical operations including systems, regulatory requirements and vendor management.
• Strong knowledge of GCP, GxP and ICH.
• Experience supporting regulatory inspections and back-room activities.
• Experience with inspection readiness, evidence collection and regulatory document requests.
• Experience supporting supplier audits and corrective actions.

Responsabilidades

• 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 vendor risk assessment, selection and compliance processes.
• Oversee vendor quality and compliance metrics, identifying trends and risks.
• Develop templates, tools and operational 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 practices.
• Partner with global and local stakeholders to strengthen operational consistency and regulatory compliance.
• Drive continuous improvement to vendor performance and inspection readiness.
• Deliver training and communications supporting systems adoption and compliance requirements.

Conocimientos

GCP knowledge

GxP knowledge

ICH knowledge

Regulatory inspections experience

Vendor management

Matrix leadership

Educación

University degree in business or relevant field

Descripción del empleo

Summary

This role is based in Barcelona Gran Via, Spain. Novartis is unable to offer relocation support. Please only apply if accessible.

Novartis operates a Hybrid working arrangement with an expectation of 12 days per month onsite.

About The Role

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.

The expected Annual Base Salary Range for this role: 63,600.00 - 118,000.00 EUR 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)