Quality Assurance Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee and delegate daily tasks to Senior QA Specialists.

• Offer guidance, coaching, mentoring, and training for team members.

• Engage in hands-on quality activities and take ownership of complex or impactful projects.

• Maintain Drug Establishment Licences for importers and manage approvals for foreign sites.

• Ensure adherence to Health Canada regulations and guidelines regarding the importation of drugs, medical devices, and natural health products.

• Manage or supervise the release of commercial drug products and clinical trial supplies into the Canadian market.

• Review and update SOPs, conduct annual product quality assessments, stability evaluations, and manage qualification and validation documentation, as well as temperature studies and artwork.

• Ensure that deviations, CAPAs, product quality complaints, change controls, and trend analyses are completed in a compliant and timely manner.

• Provide expert quality consultations to clients, including risk assessments and practical solution recommendations.

• Contribute to the development, maintenance, and continuous improvement of GMP quality systems.

• Advise various departments on Quality Assurance requirements, associated risks, and strategic approaches.

• Support or lead internal, client, third-party, and regulatory audits or inspections.

• Assist with recall and mock recall activities.

• Cultivate relationships with stakeholders, clients, foreign sites, and external partners.

• Participate in client meetings and presentations, effectively communicating Quality positions.

• Manage multiple projects, ensuring timely delivery of work within established deadlines.

• Provide training, presentations, and seminars for internal teams, clients, and external organizations.

• Complete or assist with invoice reconciliation and quotation processes.

• Adhere to confidentiality and privacy standards.

• Undertake additional responsibilities as assigned by Senior QA Management.

⛳️ Requirements

• Bachelor's degree in a pharmaceutical, scientific, or healthcare-related discipline, such as chemistry, biology, microbiology, pharmacy, or pharmacology.

• At least 10 years of Quality Assurance experience in a regulated pharmaceutical or healthcare setting.

• Minimum of 3 years in a management or supervisory role.

• Proven experience with Health Canada requirements, GMP compliance, drug importation, and Drug Establishment Licences.

• Experience in conducting vendor audits and facilitating client, third-party, or regulatory audits is an advantage.

• Consulting experience is a plus.

• Familiarity with natural health products is beneficial.

• Extensive knowledge of the Food and Drugs Act, Health Canada GMP regulations, and related guidelines.

• Strong working knowledge of DEL requirements, importation controls, GMP documentation, risk assessment, and quality systems.

• Demonstrated ability to manage, motivate, and develop team members; establish clear expectations; provide effective training; delegate tasks appropriately; and promote accountability, collaboration, and respectful professional relationships.

• Proficient in handling deviations, root cause analysis, CAPA, and risk assessment methodologies.

• Excellent written, verbal, presentation, and public-speaking abilities.

• Advanced skills in Microsoft Word and Excel.

• Capacity to quickly learn and adapt to new technologies and enterprise systems.

• Capable of working independently and within cross-functional, multidisciplinary teams.

• Willingness to travel up to 20% of the time.

🏝️ Benefits

• Comprehensive medical, dental, and vision coverage.

• Backup dependent care services.

• Adoption assistance programs.

• Infertility treatment coverage.

• Support for family building efforts.

• Solutions for behavioral health issues.

• Paid parental leave policies.

• Paid caregiver leave options.

• Access to training programs.

• Resources for professional development.

• Opportunities for mentorship.

• Employee resource groups.

• Volunteer activity options.