Quality Assurance Manager leading GMP compliance, DEL maintenance and Canadian drug-product release for Cencora. Managing QA specialists and advising pharmaceutical clients on regulated quality activities.
Responsibilities
Lead and assign the day-to-day work of Sr. QA Specialists
Provide direction, coaching, mentoring, training and cross-training
Perform hands-on quality activities and own complex or high-impact assignments
Maintain importer Drug Establishment Licences and manage foreign site approval processes
Ensure compliance with Health Canada regulations and guidance for drug, medical device and natural health product importation
Perform or oversee release of commercial drug products and clinical trial supplies to the Canadian market
Maintain and review SOPs, annual product quality reviews, stability reports, qualification and validation documentation, artwork and temperature studies
Ensure deviations, CAPAs, product quality complaints, change controls and trend analyses are completed compliantly and on time
Provide expert quality consultation to clients through risk assessment and practical solution recommendations
Contribute to development, maintenance and continual improvement of GMP quality systems
Advise departments on Quality Assurance requirements, risks and strategies
Support or lead internal, client, third-party and regulatory audits or inspections
Support recall and mock recall activities
Build relationships with stakeholders, clients, foreign sites and external partners
Participate in client meetings and presentations and communicate Quality positions
Manage multiple projects and deliver work within established timeframes
Deliver training, presentations and seminars to internal teams, clients and external organizations
Complete or support invoice reconciliation and quotation activities
Comply with confidentiality and privacy requirements
Perform other duties assigned by Senior QA Management
Requirements
Bachelor's degree in a pharmaceutical, scientific or healthcare-related field, such as chemistry, biology, microbiology, pharmacy or pharmacology
Minimum 10 years of Quality Assurance experience in a regulated pharmaceutical or healthcare environment
Minimum 3 years of people management or supervisory experience
Demonstrated experience with Health Canada requirements, GMP compliance, drug importation and Drug Establishment Licences
Experience conducting vendor audits and hosting or co-hosting client, third-party or regulatory audits is considered an asset
Experience working as a consultant is considered an asset
Experience with natural health products is considered an asset
Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidance
Strong working knowledge of DEL requirements, importation controls, GMP documentation, risk assessment and quality systems
Proven ability to manage, motivate and develop employees; set clear expectations; provide practical training; delegate effectively; and foster accountability, collaboration and respectful professional relationships
Skilled in deviations, root cause analysis, CAPA and risk assessment
Strong written, verbal, presentation, and public-speaking skills
Advanced proficiency in Microsoft Word and Excel
Ability to quickly learn and adapt to new technologies and enterprise systems
Works effectively independently and in cross-functional, multidisciplinary teams
Associate Director leading QA automation, SQL database validation, and Azure testing for EQ Bank’s commercial lending technology. Managing AQA teams and CI/CD quality initiatives on a six - month contract.
Test Development Team Lead leading automation and AI - assisted testing for Nureva’s IoT collaboration platform. Driving quality across embedded devices, applications, cloud services, and Azure connectivity.
Quality Assurance Lead Consultant delivering GMP compliance projects for pharmaceutical and health - product clients. Managing investigations, audits, quality systems, documentation, and product release.
Manual Mobile QA testing iOS and Android music - learning apps for Gismart’s Radiotech. Validating releases, A/B tests, configurations, and product quality.
QA Team Lead overseeing Nestlé Canada’s Toronto food manufacturing laboratory. Leading testing, food safety, audits, traceability, and laboratory staff development.
Bilingual software tester validating French online applications and phone systems for PLATO, a Canadian Indigenous - owned software testing services company. Testing CYARA Contact Centre and AWS Connect systems for finance - sector clients.
Ingénieur principal en qualité chez EDC, société d’État aidant les entreprises canadiennes à réussir à l’étranger. Modernisation de l’automatisation des tests et intégration de l’IA aux plateformes commerciales numériques.
Senior Quality Engineer/Lead modernizing AI - enabled testing at EDC, Canada’s export - finance corporation. Building Python and Robot Framework automation across enterprise software delivery.