Quality Management System Manager

Grifols

. Evaluate quality system processes, develop action plans, and coordinate strategic implementation of quality system initiatives and corrective actions within the plasma donor center .

Posted 10/26/2026full-timeMississauga • CanadaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance processes, including CAPA development and implementation, compliance with cGMP regulations, and effective risk management. Proven ability to lead teams, manage documentation, and analyze quality metrics to ensure donor safety and product quality.

Highest-signal resume keywords

Quality Assurance ManagementCGMP ComplianceCAPA DevelopmentProject LeadershipData Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality System EvaluationDocumentation ManagementRisk Management SystemsSOP ImplementationKPI EstablishmentInternal AuditsDeviation InvestigationQuality Analysis ReportingGMP RegulationsBiologics Manufacturing

Soft Skills

Excellent Communication SkillsOrganizational SkillsPlanning SkillsTeam LeadershipAnalytical Thinking

Tools & Technologies

MS Office

Industry Keywords

Plasma Donor CenterBiologicsMedical DeviceIn-Vitro DiagnosticsQuality ControlRegulatory ComplianceLaboratory EnvironmentDonor SafetyAdverse Event ReportingBiohazard Waste Management

About the role

Key responsibilities & impact

Evaluate quality system processes, develop action plans, and coordinate strategic implementation of quality system initiatives and corrective actions within the plasma donor center
Supervise and lead the Quality Assurance Specialist and Document and Quality Support Specialist
Manage documentation, deviation, and CAPA processes across Grifols Canadian Plasma supply chain areas
Ensure compliance with applicable regulations and company policies
Implement risk management systems and quality-control SOPs
Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety
Establish and evaluate quality-system KPIs
Oversee internal and external audits, audit responses, CAPA development, implementation, and effectiveness assessment
Investigate deviations, trends, failures, and root causes; follow up on corrective and preventive actions
Oversee product and biohazard waste shipments, labeling, documentation, and release requirements
Review unsuitable test results, unit lookback information, donor adverse-event reports, and production records
Conduct employee performance observations and ensure staff competency
Ensure supplies and materials meet quality requirements and are properly stored
Prepare quality analysis reports and resolve systemic compliance issues
Hold monthly quality meetings with Regional Quality Management
Monitor Grifols viral marker data for PPTA reporting
Coordinate departmental objectives and perform assigned tasks

Requirements

What you’ll need

Bachelor’s degree in one of allied sciences (chemistry, biology or medical technology, preferably in Pharmacy)
At least 6 years of experience in Quality Assurance, with at least 2 years in a managerial role
Minimum of 2 years of related work experience in a GMP regulated laboratory, biologics/drug manufacturing, medical device or in-vitro diagnostic environment
Project or technical leadership experience required
Experience in a cGMP regulated environment
Proficiency in MS Office
Ability to work within a highly regulated, labor-intensive environment
Ability to interpret data and facts analytically
Excellent oral and written communication skills
Effective organizational and planning skills with ability to meet deadlines