Global Good Clinical Practices / Pharmacovigilance Auditor

Novartis; Madrid; Presencial; EUR 45.000 - 84.000; Jornada completa

Descripción de la vacante

Novartis is seeking a Global GCP/PV Auditor to lead and conduct audits across Spain, with relocation support and the option to work remotely from anywhere in Spain. Travel up to 50% is required, with preference toward Madrid/Barcelona areas for occasional on-site work.

You will guide audit activities, assess compliance, support CAPA, and contribute to continuous quality improvement across global operations, ensuring alignment with GCP/GPvP standards.

Formación

• Degree in natural or biological sciences or equivalent experience.
• Approximately 5 years of experience in GCP, GPvP, clinical research, or pharma environment.
• 1–2 years of GCP auditing experience preferred.
• Strong knowledge of GCP, GPvP, and GxP regulations and guidelines.
• Ability to evaluate compliance issues objectively and manage multiple priorities.

Responsabilidades

• Plan, lead and conduct GCP/PV audits per Novartis procedures and regulations.
• Perform low-risk audits such as site, vendor, systems, and patient-oriented programs.
• Support complex audits including country orgs and higher-risk vendors.
• Provide guidance and training on audit activities to ensure quality.
• Escalate findings and support CAPA actions and mitigation plans.
• Maintain up-to-date knowledge of applicable regulations and industry expectations.

Conocimientos

GCP/GxP knowledge

Audit planning

Leadership

Stakeholder engagement

Decision-making

Educación

Degree in natural or biological sciences

Descripción del empleo

Summary

Location: Spain

Novartis is able to offer relocation support for this role!

We are looking for talented professionals across Spain to join our global audit team. This role offers the opportunity to work fully remotely, with flexibility to be based anywhere in Spain, with preference for Madrid or Barcelona area.

As a Global GCP/PV Auditor, you will help ensure that clinical and pharmacovigilance activities are conducted in line with applicable regulations, standards and internal procedures. You will plan and conduct audits, assess compliance risks, support CAPA activities and contribute to continuous quality improvement across global operations.

In this role you will lead, support and report independent GCP/PV audits and approve follow-up corrective and preventive activities according to the Novartis Quality Systems and Standards, Good Clinical Practice(GCP)/Good Pharmacovigilance Practice(GPvP) and the current GCP/PV regulations. You will provide GCP/PV related quality guidance and assist in the identification and implementation of quality assurance training needs for Global GxP Audit and other business partners.

About The Role

Please note that the role requires travel of up to 50% of the time.

Major Accountabilities

• Plan, lead, conduct, document, report and follow up on GCP/PV audits in accordance with Novartis procedures, applicable regulations, quality agreements, standards and guidance documents.
• Perform low-risk GCP/PV audits, such as investigator site audits, single-service vendor audits, systems/process audits and patient-oriented program audits.
• Support more complex audits, including country organizations, multiservice vendors and higher-risk vendor audits.
• Provide technical guidance and training on audit-related activities to support consistent audit execution and quality standards.
• Escalate critical audit findings to responsible management and support immediate follow-up actions in line with Novartis escalation procedures.
• Ensure appropriate definition, documentation and follow-up of mitigation plans where required.
• Assess the adequacy of responses and CAPA plans to audit findings in collaboration with CAPA Approvers and CAPA Coordinators.
• Maintain up-to-date knowledge of applicable regulations, standards, guidelines and industry expectations.

Obligatory Requirements

• Degree in natural or biological sciences, or equivalent combination of education and relevant experience.
• Approximately 5 years of experience in GCP, GPvP, clinical research, pharmaceutical industry, health authority or equivalent environment.
• 1–2 years of GCP auditing experience preferred.
• Strong knowledge of applicable GCP, GPvP and GxP regulations, guidelines, policies and procedures.
• Ability to evaluate compliance issues objectively, manage multiple priorities and maintain oversight across parallel activities.
• Sound decision-making and problem-solving skills, with the ability to work with a moderate level of independence.
• Strong quality and compliance mindset, with good leadership, facilitation and stakeholder engagement skills.
• Fluent English, written and spoken; additional languages are an advantage.

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

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 a minimum of 14 weeks paid parental leave.

Expected Annual Base Salary Range For Role

• Spain: EUR 45,100 – 83,700

The 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. Further details will be provided during the application process.

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 Paragraph

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:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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)