In this role you will lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents
Job Summary
In this role you will lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.
You will be required to travel up to 60% of time.
Matching Summary
In this role you will lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
Skills & Requirements
Must-have
Lead and support independent GMP audits
Assess compliance with GMP regulations
Review and approve corrective action plans
Conduct audits of manufacturing sites and suppliers
Provide technical guidance and mentoring
Maintain current knowledge of regulations
Nice-to-have
Alignment with strategic company direction
Consultation through risk-based assessments
Identify and report best practices
Experience with local Health Authorities
Key Requirements
12+ years experience in Pharmaceutical or Medical Device Industry
3 years auditing experience preferred
Strong knowledge of GMP regulations
Solid operational experience (QA/QC, manufacturing, development, regulatory health authority)
Strong experience in Sterile and/or expertise in API, Biologics, Cell&Gene therapy, etc.