[Hiring] Global Quality Assurance Specialist @Medexus Pharma Careers

Role Description

The Global Quality Assurance Specialist supports day to day Global QA activities related to external manufacturing and distribution partners for Medexus products marketed in Canada and the United States. This role performs and supports key quality processes including:

• Batch record review
• Product release
• Deviations
• Change controls
• Complaints
• CAPA
• APQRs
• Quality metrics tracking

The position helps maintain compliance with Health Canada GMP and GDP requirements and U.S. FDA cGMP standards, while contributing to audit preparation, partner oversight, and ongoing process improvement.

Qualifications

• College diploma or bachelor’s degree in a scientific or technical discipline preferred, or an equivalent combination of education and experience.
• Minimum of 6 years of Quality Assurance experience within the pharmaceutical or biotechnology industry, including batch record review, document control, product release, internal and external audits, and complaint handling.
• Working knowledge of Health Canada GMP and GDP regulations and U.S. FDA requirements.
• Proficiency with electronic Quality Management Systems (eQMS) for deviations, CAPA, change control, and document management.
• Familiarity with project management tools such as Monday.com and Smartsheet, as well as data analysis tools such as JMP is considered an asset.
• Demonstrated ability to work independently with limited supervision while collaborating effectively in a team environment.
• Proficiency in Microsoft Office, including Word, Excel, and Outlook.
• Demonstrated written and verbal communication skills.
• Experience supporting QA oversight of contract manufacturing or distribution partners is considered an asset.
• Excellent attention to detail and accuracy in documentation review.
• Excellent organizational, problem solving, and record keeping skills.

Requirements

• Provide Global Quality Assurance oversight of Contract Manufacturing Organizations (CMOs) and third-party logistics partners (3PLs) supporting the manufacture, packaging, distribution, and release of Medexus products for the Canadian and U.S. markets.
• Review and assess CMO and 3PL quality activities, including deviations, investigations, change controls, CAPA, batch records, product returns, and Product Quality Reviews (PQRs) to ensure compliance with internal procedures and applicable Health Canada and U.S. FDA requirements.
• Author and manage internal deviations, change controls, and related QA documentation associated with CMO and 3PL activities.
• Perform batch record review and product release activities, including product returns as applicable, ensuring accuracy, completeness, and compliance with established procedures and regulatory requirements.
• Manage product complaint intake, documentation, communication, and investigation with patients, pharmacies, 3PLs, and CMOs, as applicable.
• Draft internal Annual Product Quality Reviews (APQRs) for Medexus products.
• Support the preparation, coordination and review of Quality System Management Reviews (QSMRs).
• Track and trend internal and external quality metrics to support ongoing monitoring, issue identification, and continuous improvement.
• Support and, where appropriate, lead, internal and external audits, including audit readiness activities, report writing, documentation review, and follow up actions.
• Support quality and process improvement initiatives, including risk assessments, review of qualification and validation data, and trend analysis using tools such as JMP.
• Verify and monitor product shipments, temperature excursions, and lot traceability records associated with CMO and 3PL operations.
• Support commercial serialization activities with 3PL partners, including management of Incoming Serialization Verification Alerts, as applicable.
• Ensure QA procedures, work instructions, records, files, and databases related to these activities are maintained, current, accurate, and audit ready.

Benefits

• Base salary range: $70,000-$100,000
• Remote position with travel requirements up to 10% including international travel as needed.