[Hiring] Global Good Clinical Practices / Pharmacovigilance Auditor @Novartis

Role Description

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.

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.

Qualifications

• 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.

Benefits

• Competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working options, where possible.
• A minimum of 14 weeks paid parental leave.
• Performance-based bonus eligibility depending on certain performance parameters.

Company Description

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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?