SpainNovartis is able to offer relocation support for this role!We are looking for talented professionals across Spain to join our global audit team.
Envíe su CV y cualquier información adicional requerida después de haber leído esta descripción, haciendo clic en el botón de solicitud.
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 general 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.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.Assess the adequacy of responses and CAPA plans to audit findings in collaboration with CAPA Approvers and CAPA Coordinators.1-2 years of GCP auditing experience preferred.Strong quality and compliance mindset, with good leadership, facilitation and stakeholder engagement skills.Fluent English, written and spoken; 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.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. xqbhyrx
Read our brochure to learn more about our global total rewards offering: Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable.
Skills DesiredCollaboration, Data Integrity, Decision Making, Leadership, Risk ManagementSummaryLocation: Madrid ProvincialType: Full time

📌 Global Good Clinical Practices / Pharmacovigilance Auditor (España)
🏢 Novartis
📍 España