Global Auditor – Clinical Practice or Pharmacovigilance Auditor
Job ID: REQ-10024686
Location: Spain
Summary:
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 current GCP/PV regulations.
You will provide GCP/PV related quality guidance and assist in identifying and implementing quality assurance training needs for Global GxP Audit and other business partners.
The audits performed on behalf of Global GxP Audit include all audit types across GCP and PV disciplines including internal and external targets.
About the Role:
In this role, you will be required to travel up to 60% of the time.
Major Accountabilities: Plan, lead, conduct, document, report, and follow-up of GCP/PV audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documented.For this entry-level global auditor role, audits will typically be limited to low risk GCP/PV activities such as Investigator site audits, single service vendors, systems/process, Patient Oriented Programs, etc.
The auditor may assist in supporting complex audits (Country Organizations, multiservice vendors, high risk vendors, etc).Provide technical guidance and training on audit activities.Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to the Novartis requirements on Management Escalations and other relevant procedures.Ensure adequate definition and recording of mitigation plans when applicable.Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).Maintain current knowledge of regulations, standards, and guidance documents.Education:
Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience).
5 years of GCP/GPvP/clinical/industry/health authority experience or equivalent (1-2 years of GCP/PV auditing experience is preferred).
Thorough knowledge of applicable GCP, GPvP, and GxP regulations, guidelines, policies, and procedures.
Skills:
Ability to manage and objectively evaluate compliance issues.
Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision making and problem solving.
Experience with Health Authority inspections and interaction.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world.
How can we achieve this?
With our people.
It is our associates that drive us each day to reach our ambitions.
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