Global Gmp Senior Quality Auditor

Novartis

Multiple Locations
Gmp audit leadership and execution
Risk-based audit strategy development
Sterile and aseptic manufacturing expertise
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 Global GMP Senior Quality Auditor also ensures alignment with strategic direction of the company and assist in driving implementation of the applicable actions and provides consultation to Novartis business units through risk based assessments.
  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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

  • GMP audit leadership and execution
  • Risk-based audit strategy development
  • Sterile and aseptic manufacturing expertise
  • Regulatory compliance and guidance
  • Corrective action plan review
  • Quality systems and manufacturing knowledge
  • Travel up to 60%

Nice-to-have

  • Mentoring and training auditors
  • Interpersonal diplomacy and persuasion
  • Experience with Health Authorities
  • Consultation on GMP compliance
  • Continuous improvement projects

Key Requirements

  • 12+ years pharmaceutical or medical device experience
  • 3 years auditing experience preferred
  • Strong knowledge of GMP regulations
  • Fluent English written and spoken
  • Experience in sterile or related manufacturing areas

Work Rights

Not specified

Tailored Resume

Cover Letter