Manager, Quality Assurance

Overview

Manage and develop a team of Sr. QA Specialists while directly supporting complex client and quality deliverables, including Drug Establishment Licence maintenance, foreign site approvals, product and clinical trial supply release to the Canadian market, and quality and compliance documentation.

What you'll do

• Lead and assign the day-to-day work of Sr. QA Specialists, balancing client commitments, compliance risk, business needs and established timelines.
• Provide clear direction, coaching, mentoring, training and cross-training to strengthen team capability, accountability, consistency and readiness for changing priorities.
• Remain hands-on in day-to-day quality activities and take ownership of complex or high-impact assignments, identifying issues early, making timely decisions within authority and escalating appropriately.
• Maintain importer Drug Establishment Licences and manage the approval process for foreign sites supporting multiple clients.
• Ensure compliance activities associated with the importation of drugs, medical devices and natural health products are performed in accordance with applicable Health Canada regulations and guidance.
• Perform or oversee the release of commercial drug products and/or clinical trial supplies to the Canadian market for Innomar or clients, as required.
• Maintain and review internal and client quality documentation, including SOPs, annual product quality reviews, stability reports, qualification and validation protocols and reports, artwork and temperature studies.
• Ensure deviations, corrective and preventive actions, product quality complaints, change controls and associated trend analyses are completed in a compliant, thorough and timely manner.
• Provide expert consultation to clients on quality matters by assessing risks, evaluating potential impacts, and recommending practical, compliant, and sustainable solutions.
• Actively contribute to the development, maintenance and continual improvement of GMP quality systems, including addressing deficiencies or inconsistencies when identified.
• Advise other departments on Quality Assurance requirements, risks and strategies.
• Support or lead internal, client, third-party and regulatory audits or inspections, including serving as lead auditor or audit host when required.
• Support recall and mock recall activities, as required.
• Build and maintain positive, productive relationships with internal stakeholders, current and prospective clients, foreign sites and other external partners.
• Participate actively in client meetings and presentations, communicate Quality positions clearly and respond confidently to questions while remaining collaborative and solutions-focused.
• Demonstrate initiative by volunteering for new responsibilities and adapting quickly to changing priorities, emerging issues and unfamiliar situations.
• Manage multiple projects efficiently and accurately, with strong follow-through and dependable completion within established timeframes.
• Provide subject matter expertise through the delivery of training, presentations, and seminars to internal teams, clients, and external organizations.
• Complete or support invoice reconciliation and quotation activities, as assigned.
• Understand and comply with company confidentiality and privacy requirements.
• Perform other duties and tasks assigned by Senior QA Management.

What you'll need

• 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.
• 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.
• Able to lead complicated, multi-client projects, organize competing priorities, maintain attention to detail and work efficiently without compromising quality or compliance.
• Demonstrates strong written, verbal, presentation, and public-speaking skills.
• Advanced proficiency in Microsoft Word and Excel.

Nice to have

• Experience conducting vendor audits and hosting or co-hosting client, third-party or regulatory audits.
• Experience working as a consultant.
• Experience with natural health products.
• Knowledge of natural health product requirements.
• Familiarity with AI tools and their business applications.

Details

• Location: Remote, ON (Canada).
• Full-time position.
• May involve travel up to 20%.
• Work shift is not required unless business needs change.