Full Job Description
Corporate Quality & Compliance Manager
Canada Plasma Operations
About the Role
We are seeking an experienced Corporate Quality & Compliance Manager to lead and continuously improve the Quality Management System (QMS) supporting our network of plasma donation centers across Canada.
In this role, you will serve as a key quality leader responsible for ensuring regulatory compliance, donor safety, operational excellence, and continuous improvement across multiple sites. You will partner closely with Quality, Operations, Medical, Training, Regulatory Affairs, IT, and Corporate Quality teams to drive harmonized quality practices and maintain inspection readiness throughout the organization.
This is an exciting opportunity for a quality professional who thrives in a highly regulated environment and is passionate about building robust systems that support safe and compliant healthcare operations.
Key Responsibilities
Quality Management System Leadership
• Lead and maintain core Quality Management System processes, including:
o Deviations and Investigations
o Corrective and Preventive Actions (CAPA)
o Change Control
o Document Control
o Training and Learning Management Systems
o Internal Audit Programs
o Risk Management Processes
• Drive standardization and harmonization of quality processes across all plasma donation centers.
• Monitor quality system effectiveness using KPIs, metrics, and management review processes.
• Ensure ongoing compliance with applicable regulatory and corporate requirements.
Continuous Improvement & Compliance
• Lead initiatives that improve quality system effectiveness and operational compliance.
• Drive root cause analysis efforts and CAPA effectiveness programs to reduce recurring deviations.
• Monitor CAPA quality and closure timelines.
• Identify systemic quality risks and implement preventive strategies.
• Facilitate risk assessments and support risk-based decision making.
Inspection & Audit Readiness
• Maintain a continuous state of inspection readiness across the plasma center network.
• Coordinate responses to regulatory inspections, corporate audits, and third-party assessments.
• Track findings, observations, commitments, and remediation plans through completion.
• Partner with site leadership to ensure sustainable corrective actions are implemented.
Data Integrity & Quality Analytics
• Strengthen data integrity practices across quality and operational processes.
• Develop and maintain dashboards, trend analyses, and quality performance reports.
• Analyze quality data to identify emerging risks and improvement opportunities.
• Present quality metrics, compliance trends, and risk assessments to senior leadership.
Cross-Functional Partnership
• Collaborate with Operations, Medical Affairs, Regulatory Affairs, Training, IT, and Corporate Quality teams.
• Provide quality oversight for new technologies, process changes, and business initiatives.
• Mentor site quality teams and promote best practices across the organization.
• Foster a culture of quality, compliance, and continuous improvement.
Qualifications
Required
• Bachelor's degree in Life Sciences, Biology, Pharmacy, Nursing, Engineering, Quality, or a related field.
• Minimum 3 years of progressive Quality Assurance experience in a regulated environment, such as:
o Pharmaceutical
o Biologics
o Blood or Plasma Collection
o Medical Device
o Healthcare
• Strong knowledge of Quality Management Systems (QMS) and GxP principles.
• Hands-on experience with:
o Deviations and Investigations
o CAPA Management
o Change Control
o Document Management Systems
o Training Systems
o Internal Audits
• Experience supporting inspections and regulatory audits.
• Strong analytical, problem-solving, communication, and stakeholder management skills.
• Experience using electronic Quality Management Systems (eQMS).
Preferred
• Advanced degree in a related discipline.
• Experience within plasma collection, blood establishments, biologics, or blood products industries.
• Multi-site quality operations experience.
• Experience implementing and maintaining quality systems in donor center environments.
• Familiarity with Health Canada, FDA, EMA, PIC/S, or similar regulatory frameworks.
What Success Looks Like
• Consistently effective and compliant quality systems across all locations.
• Improved CAPA quality and closure performance.
• Reduced recurring deviations through effective root cause analysis.
• Strong audit and inspection outcomes.
• Increased visibility into quality performance through data-driven reporting.
• Sustainable quality culture supporting donor safety and regulatory compliance.
Work Environment & Travel
• Hybrid office, plasma center, and operational facility environment.
• Exposure to regulated healthcare and plasma collection environments.
• Up to 30% travel within Canada to support site operations, audits, inspections, and quality initiatives.
