The Global Quality Auditor performs GMP audits according to the Novartis Quality System and Standards and the current GMP regulations to ensure a high product quality and compliance with all applicable regulations. The audits performed on behalf of Compliance & Auditing may include manufacturing sites, non-manufacturing sites, development centers, quality systems, contract manufacturers and suppliers.
Plan and perform audits according to the requirements specified in the respective Novartis Quality Module.
Audits include: pre-qualification audits, routine GMP surveillance audits (both System Based audits and audit focused on special areas/functions e.g. on Stability Program), for cause audits, mock inspections at suppliers/ contractors.
Conduct pre-approval/pre-submission project reviews and mock pre-approval inspections at contractors/ suppliers level. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
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. Ensure adequate definition, recording of mitigation plan when applicable.
Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Auditee (Quality Responsible Person, QARP).
Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects etc.
Review and revise relevant procedures, as needed, support compliances activities as needed.
Maintain current knowledge of regulations and elaborate best practices auditing guideline (when applicable). Support development/training of GMP auditors.
Support HA commitments and global commitments/initiatives as an outcome of inspection findings
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Graduate degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science
Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, Spanish)
At least 10 years broad experience in Pharmaceutical Industry.
The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.
At least 3 years auditing experience, including preferably auditor certification by an industry recognized body e.g. ASQ and excellent knowledge of regulatory requirements.
Willingness to travel approx. 60% of the time
Expertise in at latest, one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
Experience and/ or interaction with local Health Authority and sporadically with other Health Authorities.
Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.
Sound and practical judgment in the interpretation and application of regulations and standards
**Position can be based either in Princeton, NJ or East Hanover, NJ**
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considered, please do so. Applications for all positions are subject to each employer's specific requirements.