Senior Pharmaceutical Quality Assurance Consultant

Lead pharmaceutical quality assurance and regulatory compliance work as a Senior Consultant based in Canada, supporting GMP documentation and product release.This senior position supports pharmaceutical, medical device, natural health product, and clinical trial supply operations. You will coordinate licences, manufacturing sites, client documentation, and Canadian product releases. The work includes quality systems, regulatory requirements, and operational processes across clients and international sites.Key Responsibilities:
Maintain importer DELs, MDELs, SLs, and applicable establishment licencesCoordinate international manufacturing and supplier site approvalsReview GMP documentation and product release recordsInvestigate deviations, complaints, and change controlsSupport audits, inspections, recalls, and quality reportingRequirements:
Bachelor's degree in pharmaceutical or healthcare-related disciplineAt least 5 years of professional Quality Assurance experienceKnowledge of Food and Drugs Act and Health Canada GMP regulationsUnderstanding of GCP, GMP, GDP, and data integrity principlesExperience with root cause analysis and CAPA implementationApply regulatory expertise, quality systems knowledge, and product release experience across Canadian healthcare and pharmaceutical operations.
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