Senior Global GCP/PV AuditorLocation: Full remote, flexible location (Barcelona or Madrid). Travel up to 60% of time.
SummaryLead, support and report independent GCP/PV audits according to NVS Quality System and applicable regulations, assess compliance, review and approve corrective action plans, and support implementation of actions.
Major Accountabilities
Support the strategic development of an effective global risk‑based audit strategy and programme;
collect, collate and incorporate input into audit strategy and plan.
Lead, plan, conduct, document and follow‑up on general quality regulatory compliance audits and assessments of GPvP according to the requirements specified in the respective Novartis Quality Module and applicable regulations, standards, quality agreements, and guidance documents.
Provide technical guidance, leadership, mentoring and training of auditors on audit related activities.
Prepare audit reports according to NVS requirements and timelinesli>
Ensure appropriateescalation of critical findings and support immediate follow‑up measures according to NVS requirements on Management Escalations and other relevant procedures.
Assess the adequacy of CAPA plans to audit findings in cooperation with Follow‑up Responsible Person (FURP) and Quality Responsible Person (QARP).
Identify and communicate quality and regulatory compliance issues to Quality Management through appropriate channels and recommend remediation.
Lead compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement as requested.
Support Mock Pre‑Approval Inspections (PAIs) and Health Authority (HA) inspections as needed.
Minimum Requirements
Education: degree in natural/biological sciences or equivalent;
advanced degree desirable.
7+ years of GCP and PV/Pharmaceutical Industry/Health Authority experience, including 3+ years of GCP or PV auditing experience.
Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
Ability to address a variety of tasks within the same timeframe while maintaining oversight and a high degree of independence.
Experience with Health Authority inspections and interaction.
Extensive knowledge of applicable GCP / PV and GxP regulations, guidelines, policies and procedures.
Good knowledge of computer systems validation and 21CFR Part 11 requirements.
Desirable Requirements
Auditor certification would be highly valued.
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Novartis People & Culture
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Benefits & Rewards
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