Novartis

Senior Global GCP/PV Auditor

Novartis

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇪🇸 Spain

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Lead, support and report independent GCP/PV audits according to the NVS Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents.
  • Review and approve corrective action plans in support of the audit observations, ensuring alignment with strategic direction of the company.
  • Assist in driving implementation of the applicable actions.
  • Travel up to 60% of time.
  • 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 of global quality regulatory compliance audits and assessments of GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents.
  • Perform activities with a high degree of independence.
  • Provide technical guidance, leadership, mentoring and training of other auditors on audit related activities.
  • Prepare audit reports according to NVS requirements and timelines.
  • Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures.
  • Assess the adequacy of responses (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 as well as 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.

Requirements

  • Education: degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience).
  • Advance degree desirable.
  • 7+ years of GCP and PV/Pharmaceutical Industry/Health Authority experience or equivalent up of which 3 years of GCP or PV auditing experience (or both).
  • 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; ability to maintain a high degree of independence with respect to decision making and problem solving.
  • 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.
  • Auditor certification would be highly valued.
Benefits
  • You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
  • Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GCPPVauditingcompliance assessmentCAPA planscomputer systems validation21CFR Part 11risk-based audit strategyquality regulatory complianceinspection readiness
Soft skills
leadershipmentoringindependent decision makingproblem solvingorganizational skillscommunicationstrategic developmentoversighttechnical guidancecollaboration
Certifications
auditor certification