Quality and Patient Safety Associate

Remote – Toronto, ON

Our client, a leading organization in the pharmaceutical industry, is seeking a Quality & Patient Safety Coordinator to join their team on a 12-month contract basis. This role will support quality assurance, quality control and safety-related activities, ensuring compliance with internal procedures and applicable regulatory requirements. The successful candidate will work cross-functionally across quality, safety, regulatory, and medical teams, providing broad support while managing a wide range of day-to-day operational activities.

This role suits a versatile, flexible professional who thrives on multitasking in a fast-paced environment.

• Support pharmacovigilance and quality processes in accordance with company procedures and regulatory requirements.
• Review, process, and maintain safety and quality-related documentation, ensuring accuracy and completeness.
• Monitor, document, and elevate product complaints, adverse events, deviations, and other quality-related incidents as required.
• Assist with investigations, root cause analysis, corrective and preventive actions (CAPAs), and follow-up activities.
• Maintain accurate records and data within relevant quality and safety management systems.
• Collaborate with cross-functional stakeholders, including regulatory affairs, medical affairs, quality assurance, and operations teams.
• Support audits, inspections, and compliance activities, including document preparation and follow-up actions.
• Ensure adherence to applicable regulations, guidelines, standard operating procedures, and quality standards.
• Respond to internal and external inquiries related to quality and product safety processes.
• Manage 3PL documentation request follow-ups and metrics/Temp Tale reconciliation, including pre-review of temperature excursion and destruction records.
• Maintain reference document management processes, including all Veeva QC document uploads and approvals (e.g., SOPs).
• Oversee proof-of-delivery (POD) tracking and resolution.
• Manage shipping notifications and forecasts, including pre-review of Certificates of Analysis (CoAs) for tickets and coordinating ticket requests with sites, assessing quality impact.
• Provide broad, hands-on administrative support to the quality team, flexibly balancing shifting priorities across QA, PV, and QC functions.

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related discipline.
• 3-5 years of experience across patient safety, quality assurance, and quality control, within pharmaceutical/biotechnology environments.
• Demonstrated experience in project management, including planning, execution, and coordination of cross-functional activities.
• Experience managing change controls, deviations, and supporting internal and external audits within a regulated environment.
• Understanding of GxP, pharmacovigilance, and/or quality management principles.
• Experience reviewing technical, scientific, or regulated documentation with strong attention to detail.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong verbal and written communication skills.
• Proficiency with electronic quality, safety, or data management systems is considered an asset.
• Experience supporting both quality and pharmacovigilance activities within a small or mid-sized organization is considered an asset.

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