Quality and Patient Safety Associate

Brunel; Toronto; Híbrido; CAD 65 000 - 90 000; Tempo integral

Resumo da oferta

Brunel is seeking a Quality and Patient Safety Coordinator for a 12-month contract, with remote work option from Toronto, ON. The role supports quality assurance, quality control and safety activities, ensuring compliance with internal procedures and regulatory requirements while collaborating across quality, safety, regulatory, and medical teams.

You will review documentation, assist with investigations and CAPAs, manage safety and quality records, and support audits and inspections.

Qualificações

• 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.
• 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.
• Experience supporting both quality and pharmacovigilance activities within a small or mid-sized organization is considered an asset.

Responsabilidades

• 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, SOPs, and quality standards.
• Respond to internal and external inquiries related to quality and product safety processes.
• Manage 3PL documentation request follow-ups and metrics/TempTale 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.

Conhecimentos

Project management

Cross-functional coordination

Attention to detail

Prioritization

Verbal and written communication

Formação académica

Bachelor's degree in Life Sciences

Related discipline (Pharmacy/Biotechnology/Chemistry)

Ferramentas

Electronic quality/safety/data management systems

Descrição da oferta de emprego

Quality and Patient Safety Coordinator (12-month contract)

Remote – Toronto, ON

Introduction

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.

Responsibilities

• 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/TempTale 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.

Requirements

• 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.

About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.