Site Quality Leader

Charles City Site Quality LeadLocation: Charles City, IARole DescriptionThe Charles City Site Quality Lead role is accountable for product quality and the site's regulatory compliance standing, ensuring adherence to all regulatory compliance requirements and cGMPs, maintaining a state of Inspection Readiness and ensuring a continuous supply of high-quality products from the site.The Site Quality Lead champions the quality culture and takes proactive steps to ensure a high level of quality and compliance at the site.The position reports to the Bio/BioPharma Platform Quality Leader.The Site Quality Lead is a member of the Site Leadership Team and participates in setting the strategic direction of the quality unit and the site as well as directing day-to-day quality operations. The position also co-chairs the site Quality Council (with the Site Lead) to drive continuous improvement and compliance objectives as well as prioritizing quality culture improvement initiatives.The role has ownership of the Site Risk Assessment Process – leading the Site Leadership through the process on a predetermined cadence.The Quality Lead uses data and metrics to drive continuous improvement in site quality management systems as well as Product Quality. Additionally – the role is responsible for creating and executing the Site Quality Roadmap.Stewardship and Leadership of the Quality Culture within the Quality Function as well as across the Site.Establishing and Reinforcing the Quality Culture on the Site; Contributing member of the Site Leadership TeamImplementation of Quality Standards and ensure sustainability of the Quality Management SystemsMaintains Site Inspection Readiness for all applicable regulatory agencies including USDA, VMD, and European Agencies and acts as the company point of contact to lead inspection readiness for the site.Ensure that products are manufactured and released in compliance with pertinent Regulatory standards and Registration Files (and requirements of appropriate Regulatory Bodies) and partnering with the regulatory team on all activities relating to regulatory compliance.Overall Site Product Quality Stewardship owner and accountability.Stewardship and Ownership of Site Quality Management SystemPromote Compliance and remediate Audit findings and ensure quality standards are maintained throughout the siteEnsuring QC Testing meets Regulatory Compliance and GMPs via overseeing development and implementation of standards, methods and procedures for inspecting, testing and analyzing both raw materials and finished products.Proactive Ownership of the Site Risk Assessment process including oversight of the supplier quality programs, including supplier audits and supplier qualification processes.Oversee the development and implementation of the Quality Plan / Quality Road MapCo-Leadership of Site Quality Council and MetricsDevelop metrics to deliver product and process improvements.Ensure the Validation Master Plan is compliant and up to date. (Validation strategy and site compliance)Collect and analyze process data for new or modified products/processes.Investigates Quality related Customer ComplaintsCollaborate with other organizations/sites leaders concerning quality management system activitiesStaff and Leadership ResponsibilitiesChampion Leadership Development / Coaching of Staff; Creation of Learning OrganizationEnsure Training and Development plans are in place for all Quality associates.Development of Site Quality budget and resource planning for roll-up to the Site and Company budget.Support the development of Quality goals and targets as part of the organization's strategic plan.Organizational RelationshipsThis position will achieve results through Leadership of Colleagues with a direct reporting relationship as well as indirectly through partnership and collaboration with the site Lead, the extended site Leadership team, and company functions as listed below* to assure quality goals and strategic objectives are met.*Quality Platform Lead, Global Quality Organization including Quality Systems and Standards (QSS) and Global Quality Compliance Auditing. Bio/BioPharma Platform Leadership Team, GMS Leadership Team, Site Enabling Functions (ie: Engineering; GMT; Finance, HR etc), Operational Excellence, Regulatory Affairs, Veterinary Medicine Research and DevelopmentEducation and ExperienceBiological, Chemistry or Engineering BS / MS / PhDDemonstrated significant leadership experience in a Quality Role in Pharmaceutical / Vaccine / Animal Health / Human Health manufacturing.Operations or Quality Manufacturing preferredUSDA and European Agencies regulated work experiences desiredFluent with Six Sigma and/or Lean ManufacturingTechnical Skills RequirementsExcellent communicator and collaboratorDoes well in a Change Management environment, Acts as a Change AgentProblem solver, root cause analysis methodologyProcess oriented mindset; data and continuous improvement orientationAble to work well in complex environment.Physical Position RequirementsPosition located in Charles City, IowaSome off-site travelOccasional non-core hour work anticipated.Acronym DefinitionsGMT: Global Manufacturing TechnologyQSS: Quality Systems and StandardsUSDA: United States Department of AgricultureVMD: Veterinary Medicines Directorate (UK Regulatory Agency)