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
Senior Internal Auditor strengthening controls for Innergex, an independent renewable energy producer. Planning financial and non - financial audits, testing controls, and recommending improvements.
Energy Compliance Auditor conducting attestation engagements for renewable fuel compliance. Analyze data and maintain knowledge of regulatory standards and changes.
Senior Auditor focusing on internal audits within Canada’s financial services industry. Collaborating closely with management to ensure strong internal controls across the organization at Sun Life.
Marine Compliance Auditor performing technical compliance audits in the marine fleet at Bridgemans Services Group. Ensuring adherence to HSEQ management systems and regulatory frameworks in Canadian waters.