Global GMP Auditor Role at Novartis, Apply Now!
Are you an experienced quality professional ready to ensure global GMP compliance? Novartis is hiring a Global GMP Auditor to lead critical audits across international sites, ensuring regulatory excellence and product integrity. This high-impact role combines technical expertise with global exposure, offering an exciting opportunity to drive compliance standards across manufacturing, development, and supply chains. Discover how you can shape global health with Novartis.
Job Posting: Global GMP Auditor at Novartis
Job ID: REQ-10048543
Summary for Global GMP Auditor Role:
Lead, support, and report independent GMP audits according to the Novartis Quality System and current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of audit observations.
About the Role
Key Responsibilities:
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Plan, lead, conduct, document, report, and follow up on GMP audits in line with Novartis procedures and global standards.
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Focus on mid to low-risk manufacturing and GMP activities based on expertise.
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Provide technical guidance and training related to audit activities.
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Escalate critical findings and support follow-up actions per Novartis escalation requirements.
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Define and record mitigation plans as needed as Global GMP Auditor.
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Assess CAPA plan adequacy with QA and Auditee stakeholders.
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Maintain up-to-date knowledge of regulations, standards, and guidance documents.
Commitment to Diversity & Inclusion:
We are dedicated to creating an inclusive work environment and building diverse teams that reflect the communities we serve.
Essential Requirements:
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Audit execution as per schedule.
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Timely audit reporting and CAPA plan reviews in line with SOPs.
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Conduct follow-ups and escalations per SOPs as Global GMP Auditor.
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Support compliance activities as defined.
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Clear and complete communication with business partners.
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Successful completion of Novartis Basic GxP Systems Auditing training.
Desirable Requirements:
Financial Responsibility:
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As per Novartis rules.
Organizational Impact:
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Timely audits and communication prevent regulatory incidents preferred for Global GMP Auditor.
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Add value by supporting Audit and Incident Management.
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Help ensure compliance and promote quality improvements.
Ideal Background:
Education:
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Degree in Chemistry, Pharmacy, Biology, Engineering, or related science preferred for Global GMP Auditor.
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Other degrees may be accepted with relevant experience.
Languages:
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Excellent English communication skills.
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Knowledge of a second language (German, French, Italian, Chinese, or Spanish) is preferred.
Experience:
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10+ years in the Pharmaceutical or Medical Device industry.
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Operational experience in QA/QC, manufacturing, or development.
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3 years preferred auditing experience with strong regulatory knowledge.
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Willingness to travel 60% of the time.
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Expertise in at least one of the following: Drug Product Manufacturing, Lab Activities, Medical Devices, API, Excipients, Sterile Production, Biologics, Microbiology, CSV, Packaging, or Quality Systems.
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Experience working with or at health authorities.
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Strong interpersonal skills, diplomacy, and persuasive communication.
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Sound judgment in interpreting and applying regulations.
Keywords: Novartis, GMP Auditor, Pharmaceutical, Medical Device, Quality Assurance, Compliance
