Global Good Clinical Practices (España)

Global Good Clinical Practices (España)

07 sep
|
Other
|
España

07 sep

Other

España

Summary

LI-Remote
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 General 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.
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📌 Global Good Clinical Practices (España)
🏢 Other
📍 España

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