Assistant Cost Manager supporting Arcadis’ rail and linear infrastructure programs across Ontario. Managing forecasting, earned value reporting, cost baselines, and change control.
About the role
- Quality Management System Manager overseeing quality systems, audits, CAPA, and donor safety. Supporting Grifols’ plasma-derived healthcare operations in Canada.
Responsibilities
- 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
- 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
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