Leads the implementation, maintenance and continual improvement of the site Quality Management System (QMS) and its performance. Leads high-impact projects that aim to optimize cost, quality, and operational performance. Serves as the primary site lead for continuous improvement, influencing leadership and partners to embed sustainable best practices. Mentors and guides other staff, providing expertise in advanced methodologies and change management. Acts as a key driver of operational excellence within the site.ResponsibilitiesProvides leadership for QMS, ensuring compliance with ISO, cGMP and corporate quality standardsProvides root cause analysis and corrective/preventative action plan support to site leadershipReviews, CAPAs, spoilage incidents, and other errors for designated high risk accounts, and reviews and approves root cause analysis efforts by site leadership, and corrective/preventive actions to ensure the risk of repeat occurrence is reduced or eliminated.Oversees internal audits and QMS performance metrics, presenting findings to site leadership through regular Management ReviewsDevelops and deploys advanced process improvement methodologies to optimize cost, quality, and efficiencyLeads improvement projects, including EHS program development and sustainability for assigned programsMonitors quality related training requirements, including maintaining an effective level of trained quality resourcesEnsures conformance with overall company standards relating to documentation and record retention.Assists in the identification, development, and implementation of proactive programs designed to reduce injuries.Provides expertise in EHS initiatives, including focus groups, safety programs, and change management.
