Quality Management System Manager

Position title: Quality Management System Manager

Reports to: Corporate Quality Director.

Position Summary:

The Quality System Management Manager is responsible for evaluating quality system processes, developing action plans, and coordinating the strategic implementation of quality system initiatives and corrective actions within the plasma donor center. In this role, the manager provides direct supervision and leadership to the Quality Assurance Specialist and the Document and Quality Support Specialist, ensuring the effective execution of quality management activities and continuous process improvement.

The Quality System Management Manager is accountable for ensuring the effective management of the Quality System and for monitoring, tracking, and recording all activities that directly or indirectly impact product quality, donor suitability, donor safety, and GxP processes across the Plasma Supply Chain. The role also includes conducting periodic assessments of the Quality System through the analysis of established key performance indicators (KPIs), identifying opportunities for improvement, and supporting compliance with applicable quality and regulatory requirements.

Key responsibilities:

• Directs and monitors processes and ensure proper implementation of Quality systems (Documentation, Deviation and CAPA management) in Grifols Canadian Plasma supply chain areas. Ensure compliance with all regulations as mandated by the applicable regulatory authorities and company policies in timely manner and without overdue.
• Ensures the implementation of a robust Risk Management system among Plasma Supply Chain areas.
• Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
• Collaborates with the Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
• Establishes KPI related to Quality systems and evaluate through the different Quality system KPI’s among Plasma Supply Chain areas.
• Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, development and implementation of corrective/preventative (CAPA) actions, development and assessment of CAPA effectiveness.
• Assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct.
• Documents, investigates, and performs root-cause analysis for deviations, specifically in how they relate to the safety of the donor and the quality of the product.
• Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
• Oversees product and biohazard waste shipments: Ensures shipments meet regulatory and customer specifications and product release requirements; ensures accurate labeling and documentation.
• Ensures that documentation of unsuitable test results, unit lookback information, and all associated actions is complete and reviewed.
• Ensures that donor adverse event reports and the applicable related documentation is complete and reviewed.
• Performs periodic employee performance observations to ensure staff competency.
• Ensures all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Working with Center Management, initiates appropriate investigations for any non-conformances and anomalies.
• Ensures donor and other production records are reviewed, and donors are deferred and reinstated according to approved procedures.
• Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues.
• Holds monthly quality meetings with Regional Quality Management to communicate status updates and manage action outcomes. Working with them, performs other duties as needed to ensure donor and product safety at the center.
• Monitors Grifols viral marker data for PPTA reporting.
• Coordinate established departmental objectives and achieve them with the subordinates.
• Perform assigned tasks by direct manager.

Required Skills, Qualifications and Experience:

• Bachelor’s degree in one of allied sciences (chemistry, biology or medical technology, preferably in Pharmacy).
• Post-graduate certification in Quality Management preferred.
• At least 6 years of experience in Quality Assurance with at least 2 years in managerial role.
• Typically requires a 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.
• Supervisory or management experience preferred, experience managing remote staff helpful.
• Experience in a cGMP regulated environment.
• Proficiency in MS Office knowledge.
• Ability to work within a highly regulated, labor-intensive environment.
• Analytical and enquiring mind with the ability to interpret data and facts.
• Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups.
• Effective organizational and planning skills with ability to meeting deadlines required.

The salary range for this position is currently being assessed and will be disclosed upon completion of the compensation review process, in accordance with applicable transparency requirements.

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