In this role, you will lead, support, and report independent GCP/PV audits and approve follow-up corrective and preventive activities according to Novartis Quality Systems and Standards, Good Clinical Practice (GCP)/Good Pharmacovigilance Practice (GPvP), and current 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 types across GCP and PV disciplines, including internal and external targets.About the Role
We pursue talented professionals across Spain! This position offers the possibility of being fully remote, with flexibility in location. We’re excited to welcome you whether you're based in
Madrid
or
Barcelona .Please note that
the role requires travel of up to 60% of the time.Major accountabilities:
Plan, lead, conduct, document, report, and follow-up GCP/PV audits according to Novartis procedures and applicable regulations, standards, quality agreements, and guidance.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.Support complex audits (Country Organizations, multiservice vendors, high-risk vendors, etc).Provide technical guidance and training on audit activities.Ensure appropriate escalation to management in case of critical audit findings and support immediate follow-up measures according to Novartis procedures.Assess the adequacy of responses (CAPA plans) to audit findings in collaboration with CAPA Approver and CAPA Coordinator.Maintain current knowledge of regulations, standards, and guidance documents.Education:
Degree in natural/biological sciences or equivalent (or a mix of education and experience).Require 5 years of GCP/GPvP/clinical/industry/health authority experience or equivalent;
1-2 years of GCP auditing experience preferred.Ability to manage compliance issues and evaluate tasks objectively while maintaining independence.Thorough knowledge of applicable GCP, GPvP, and GxP regulations, guidelines, policies, and procedures.Experience with Health Authority inspections and interactions.Good leadership and facilitation skills in quality and compliance.Fluent in English, written and spoken;
additional languages are a plus.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 to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Learn moreJoin our Novartis Network:
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https:
//talentnetwork.Novartis.Com/networkCommitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams that reflect the patients and communities we serve.
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