Senior Director of Quality Location: Winnipeg, MB Position Summary Our client, a global leader in developing and delivering critical healthcare solutions, is looking for a Senior Director of Quality to oversee all quality assurance (QA) and quality control (QC) operations. This individual will ensure compliance with regulatory requirements, enhance quality systems, and foster a culture of continuous improvement. As a key member of the site leadership team, the Senior Director will align quality operations with business goals, ensuring product safety, efficacy, and regulatory adherence. This position is onsite in Winnipeg, MB. Key Responsibilities Lead and develop the quality team to foster excellence and collaboration. Set and implement the strategic vision for quality operations in alignment with corporate and site goals. Serve as the primary quality representative in interactions with regulatory agencies, customers, and internal stakeholders. Ensure compliance with Health Canada, FDA, EMA, and other global regulatory requirements. Manage and oversee regulatory inspections, audits, and follow-up actions. Maintain a robust quality management system (QMS) to meet cGMP and other applicable standards. Oversee quality assurance, quality control, and quality systems functions, including release testing, deviations, CAPA, change control, and document management. Implement and sustain quality metrics to monitor performance and drive improvements. Collaborate cross-functionally with manufacturing, R&D, and supply chain to ensure product quality throughout the lifecycle. Drive initiatives to improve quality processes, systems, and tools to enhance efficiency and effectiveness….
