Global GMP Quality Auditor

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

• Plan, lead, and conduct GMP audits across global operations and external partners.

• Evaluate compliance with regulations, quality standards, procedures, and guidance documents.

• Record audit observations, draft reports, and communicate findings to stakeholders.

• Review and endorse corrective and preventive action plans that address audit findings.

• Provide expert advice and training on audit-related activities.

• Elevate critical compliance issues and assist in timely mitigation efforts.

• Maintain up-to-date knowledge of evolving regulations, industry standards, and quality expectations.

⛳️ Requirements

• A degree in Chemistry, Pharmacy, Biology, Engineering, or another related scientific field; other degrees with relevant experience may also be considered.

• At least 10 years of extensive experience in the pharmaceutical or medical device sector, including QA/QC management and manufacturing, development, or relevant regulatory health authority experience.

• Proficiency 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.

• Comprehensive knowledge of regulatory requirements and experience with local and other Health Authorities.

• Sound 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 proficiency in both French and English, both spoken and written.

• English proficiency is required for national and international meetings and for reviewing scientific and strategic materials.

• A minimum of 3 years of auditing experience is preferred.

• Proficiency in an additional language such as German, French, Italian, Chinese, or Spanish is an advantage.

🏝️ Benefits

• No relocation support offered.

• Commitment to diversity and inclusion.

• A global healthcare organization atmosphere.

• Opportunity to engage with diverse manufacturing sites, development centers, contract manufacturers, laboratories, warehouses, and suppliers.

• Chance to influence positive change in healthcare.