Global GMP Quality Auditor

Posted 21 hours ago

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About the role

  • Global GMP Quality Auditor ensuring pharmaceutical and medical-device compliance for Novartis. Leading global audits, assessing risks, and strengthening quality systems and patient safety.

Responsibilities

  • Plan, lead, and execute GMP audits across global operations and external partners
  • Assess compliance with regulations, quality standards, procedures, and guidance documents
  • Document audit observations, prepare reports, and communicate findings to stakeholders
  • Review and approve corrective and preventive action plans addressing audit findings
  • Provide expert guidance and training on audit activities
  • Escalate critical compliance issues and support timely mitigation activities
  • Maintain expertise in evolving regulations, industry standards, and quality expectations

Requirements

  • Degree in Chemistry, Pharmacy, Biology, Engineering, or another related scientific discipline; other degrees with relevant experience may be considered
  • Minimum 10 years of broad experience in the pharmaceutical or medical device industry, including QA/QC management and manufacturing, development, or relevant regulatory health authority experience
  • Expertise in at least one area: drug product manufacturing, biologics, sterile manufacturing, laboratories, microbiology, packaging, active pharmaceutical ingredients, excipients, medical devices, computer system validation, or quality systems
  • Excellent knowledge of regulatory requirements and experience with local and other Health Authorities
  • Sound and practical judgment in interpreting and applying regulations and standards
  • Strong interpersonal skills, including diplomacy, persuasion, and stakeholder management
  • Willingness to travel approximately 60% globally
  • Advanced French and English speaking and writing proficiency
  • English proficiency required for national and international meetings and reviewing scientific and strategic materials
  • 3 years auditing experience preferred
  • Proficiency in an additional language such as German, French, Italian, Chinese, or Spanish is desirable

Benefits

  • No relocation support offered
  • Commitment to diversity and inclusion
  • Global healthcare organization environment
  • Opportunity to work with diverse manufacturing sites, development centers, contract manufacturers, laboratories, warehouses, and suppliers
  • Opportunity to influence positive change in healthcare

Job title

Job type

Full Time

Experience level

SeniorLead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

RemoteCanada

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