US-NJ, Global Quality Auditor Apheresis/Clinical Laboratory 227632BR-MZ
Global Quality Auditor Apheresis/Clinical Laboratory
Novartis Technical Operations
East Hanover, NJ
Perform GTP/GMP audits according to the Novartis Quality System and Standards and the current GTP/GMP regulations to ensure high product quality and in 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 (Apheresis Sites are considered suppliers).
Plan and perform audits according to the requirements specified in the respective Novartis Quality Module.
Audits include: pre-qualification audits, routine GTP/GMP prequalification and surveillance audits (both System Based audits and audit focused on special areas/functions e.g. co-managed clinical studies at suppliers/ contractors.
Provide regulatory guidance for timely remediation and recommendations regarding GTPs & GMPs.
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 the Quality Responsible Person, Follow-up Responsible Person and Auditee
Act as GTP/GMP compliance consultant for GTP/GMP trainings, task forces, continuous improvement projects etc.
Review and revise relevant procedures, as needed, support compliance activities as needed.
Maintain current knowledge of regulations and elaborate best practices auditing guideline (when applicable).
Support development/training of GTP/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.
Bachelor degree in Immunology Microbiology, Clinical Laboratory Science, Medical Technology, Nursing or other related Life 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 5 years broad experience in Biotech (cell therapy, Cell/gene technology, diagnostics) GTP/GMP Industry.
The operational experience should include clinical laboratory experience in blood or tissue banking or other relevant experience e.g. working at a clinical laboratory or apheresis center.
At least 3 years auditing experience, including preferably auditor certification by an industry recognized body e.g. ASQ or AATB and excellent knowledge of regulatory requirements preferred.
Willingness to travel approx. 60% of the time
Expertise in the following areas: Clinical Laboratories activities, Sterile Processing, Biologics, Microbiology, Computer System Validation, Quality Systems, Good Clinical Practices.
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 in East Hanover, NJ or Princeton, NJ
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