Vendor Operations Lead - Global Clinical Operations (GCO)

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.; Barcelona; Híbrido; EUR 64.000 - 118.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks parental leave

Descripción de la vacante

Novartis Farmacéutica, S.A. in Barcelona is seeking a Vendor Operations Lead for Global Clinical Operations (GCO). The role focuses on inspection readiness, regulatory compliance, and strengthening vendor governance across global partnerships. Hybrid work with onsite days in Barcelona.

The position requires extensive experience in clinical operations, strong GCP/GxP knowledge, and a track record of managing vendor relationships and audits. Excellent stakeholder collaboration is essential.

Formación

• University degree in business or a relevant field.
• 8–10+ years in clinical operations with vendor management.
• Strong knowledge of GCP, GxP and ICH regulations.
• Experience supporting regulatory inspections and audits.
• Experience with corrective and preventive actions (CAPA).

Responsabilidades

• Develop and implement vendor operations standards, processes, and governance.
• Lead inspection readiness and support regulatory inspections.
• Ensure vendor risk assessment and compliance processes.
• Oversee vendor quality metrics and improvement opportunities.
• Provide training and support for systems and compliance adoption.
• Collaborate with global and local stakeholders to ensure consistency.
• Drive continuous improvement in vendor performance and readiness.
• Develop templates and tools for vendor governance.

Conocimientos

Vendor compliance

Inspection readiness

Regulatory requirements

Quality management

Audit support

Vendor management

GCP knowledge

Cross-functional leadership

Educación

University degree in business or relevant field

Descripción del empleo

Salary Range: €63,600.00 - €118,000.00 Band Level 5

Job Description Summary #LI-Hybrid 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.

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. 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.

Skills Desired

• Change Management
• Clinical Operations
• Compliance Requirements
• 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