Canada
Onsite
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Quality Assurance Specialist - Consultant based in Canada.
As a Senior Quality Assurance Specialist, you will support quality assurance and regulatory compliance activities for pharmaceutical, medical device, natural health product, and clinical trial supply operations in the Canadian market. You will help maintain establishment licences, coordinate product release activities, and ensure that quality documentation meets applicable regulatory standards. Working closely with clients, international manufacturing sites, and internal teams, you will contribute to the effective management of quality systems and operational processes. The role also involves investigating deviations and product complaints, managing change controls, and supporting audits, inspections, and recalls. You will contribute to continuous improvement initiatives, quality reporting, and the development of procedures while providing guidance to colleagues when needed. This is an opportunity to apply your regulatory expertise in a collaborative, client-focused consulting environment within the healthcare and pharmaceutical sector.
Support the maintenance of importer Drug Establishment Licences (DELs), Medical Device Establishment Licences (MDELs), Site Licences (SLs), and other applicable establishment licences.
Coordinate the approval process for a large number of international manufacturing and supplier sites across multiple clients.
Liaise with clients and foreign sites to obtain, review, and update master documentation, ensuring compliance with Good Manufacturing Practices (GMP) and product release requirements.
Coordinate the release of commercial drug products, medical devices, natural health products, and clinical trial supplies for the Canadian market, as required.
Review and assess product release documentation in a timely manner, including manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other supporting records.
Assist management with preparing routine quality performance indicators (KPIs) and generating client-specific reports, acting as a Team Lead when required.
Maintain and review internal and client quality documentation, including Standard Operating Procedures (SOPs), Annual Product Quality Reviews (APQRs), stability reports, qualification and validation protocols and reports, artwork, and temperature studies.
Manage deviation investigations, including preparing reports, conducting root cause analysis, and performing trend analysis.
Process Product Quality Complaints (PQCs), including documentation, reporting, and trend analysis.
Manage Change Control Requests (CCRs), including associated reports and trend analysis.
Support the development, revision, and implementation of quality assurance policies and procedures, taking on Team Lead responsibilities when required.
Maintain an effective document management and retrieval system for records received from clients and international sites, as well as documentation submitted to Health Canada.
Provide quality assurance support during internal, client, third-party, and regulatory audits and inspections.
Support client and internal product recalls and mock recall exercises, acting as a Team Lead when required.
Build and maintain productive relationships with internal and external stakeholders, including prospective clients.
Participate in project teams and advise other departments on quality assurance matters, compliance requirements, and improvement strategies.
Travel up to 20% may be required.
Bachelor's degree in a pharmaceutical or healthcare-related discipline, such as Chemistry, Biology, Microbiology, Pharmacy, or Pharmacology.
At least 5 years of professional experience in Quality Assurance.
Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations, and related regulatory guidelines.
Strong understanding of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and data integrity principles.
Demonstrated experience managing deviations, conducting root cause analyses, and implementing Corrective and Preventive Actions (CAPA).
Ability to prioritize, coordinate, and complete multiple projects within established deadlines.
Strong problem-solving skills, with the ability to identify practical solutions to regulatory compliance and operational challenges.
Excellent attention to detail, data analysis capabilities, and the ability to communicate findings effectively.
Strong written and verbal communication skills.
Ability to work independently under general guidance while collaborating effectively with cross-functional teams and maintaining positive professional relationships.
Effective workload management and organizational skills, with the ability to apply established procedures and precedents to resolve routine issues.
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Adobe Acrobat, and other standard productivity applications.
Ability to quickly become proficient in business platforms and electronic systems, including electronic Quality Management Systems (eQMS), Environmental Management Systems (EMS), Warehouse Management Systems (WMS), and Customer Relationship Management (CRM) tools.
Familiarity with Quality Management Systems (QMS) and standard quality documentation processes.
Regulatory Affairs or Quality Assurance certification is considered an asset.
Experience conducting vendor audits is an advantage.
Experience hosting or co-hosting client audits is an advantage.
Previous experience in an operations environment is preferred.
ASQ Certified Quality Auditor (CQA), ISO 9001 Lead Auditor (QMS), or an equivalent certification is preferred.
Comprehensive health coverage, including medical, dental, and vision care.
Life insurance and short-term and long-term disability coverage.
Wellness resources supporting physical, emotional, financial, and social well-being.
Support for working families, which may include backup dependent care, adoption assistance, infertility coverage, and family-building support.
Behavioral health resources and support services.
Paid parental leave and paid caregiver leave.
Training programs and professional development resources.
Mentorship opportunities to support career growth and knowledge sharing.
Opportunities to participate in employee resource groups and volunteer activities.
An inclusive workplace focused on teamwork, professional growth, and employee well-being.
