The Senior Director of Quality Compliance is responsible for managing the QA function within the established legal guidelines and internal standards to ensure the production of the highest quality products in the safest and most efficient manner. Specifically, within this role the Senior Director of Quality Compliance ensures compliance with FDA regulations mandated in 21 CFR Part 111 and 117 (FSMA).
Functions and duties of this role include, but are not limited to: Leads development, implementation, enforcement, and continuous improvement of established policies, strategies, and procedures related to quality systems and food safety to achieve company quality-related goals and objectivesLead cross functional teams to champion the resolution of key quality issues. Develops (with VP of QA/RA) actions plans and recommendations for the Leadership Team on major quality and safety concerns that could lead to business interruptionLeads out of specification investigations. Investigates test data for raw materials and finished products between teams in Product Development, co-manufacturers, 3rd Party Laboratories and suppliersLeads development, implementation, and maintenance of company Technology Solutions for Quality Management (e.g., Viva Quality One, Product Lifecycle Management, Viva Safety)Provides quality and technical support to Product Development teams in the development and implementation of company productsStatistically analyze quality data and identify potential problem areas to prevent issuesResponsible for qualifying 3rd party laboratories to ensure compliance with ISO17025 and GLPManages certification programs for products to ensure products are following the requirements and procedures imposed by these agencies through extensive product testing and certificationsLeads international program – collaborates with key stakeholders on H&W international team. Ensures all documentation and change management requirements are met. Supports international team in reviewing / approving Product Labels and Product License Applications for international marketsCoordinates and helps troubleshoot raw material deviations between company suppliers, co-manufacturers, supplier quality, and sourcingLeads change management program. Ensures documentation is properly routed, managed, disseminated, implemented, and trained onResponsible for raw material and product risk assessments process on raw materials and finished goods to determine appropriate risk mitigation and statistically sound testing protocolsSupports company Quality Assurance co-man group and supplier group to implement corrective actions to reverse negative trends in manufacturing related consumer complaints. Drive root cause analyses, corrective actions, and continuous improvement activitiesResponsible for the consumer complaint program. Ensures that adverse event complaints are properly documented and investigated. Enforces and refines guidelines for forwarding adverse event (AER) contacts to third party resource for evaluation of severe adverse events (SAER)Develops, monitors, and reports on relevant supplier KPIs and scorecards to drive continuous improvementEnsures effective risk mitigation management to reduce risk and interruption in supply and co-manufacturing operationsLeads the CAPA management program. Ensures CAPA's are captured, documented, checked for effectiveness, and closedLeads departmental staffing and people development strategies to ensure technical competence, creativity, teamwork and broad business knowledge leading to continued managerial and technical leadership to Quality and Food SafetyLeads internal audit program to ensure compliance with the Quality SystemProvides the business with supplemental compliance with the Quality System connections / network of subject matter experts and through building strategic partnerships with identified third partiesSupport the department and company Health & Wellbeing QA-RA with other projects as requiredJob RequirementsThe successful candidate will have the following qualifications: A minimum of a bachelor's degree from an accredited college or university in a related field or equivalent combination of education, training and experience that provides the required knowledge, skills, and abilitiesMaster's degree from an accredited university in a related field or equivalent combination of education, training and experience that provides the required knowledge, skills, and abilities preferred12+ years of relevant Quality Assurance experience in the food / supplement industryStrong understanding of FDA regulations for Foods FDMA (21 CFR part 117) and Dietary Supplements (21 CFR part 111)Working knowledge of plant layout and manufacturing operations to effectively troubleshoot and correct production related problems and recognize constraints and limitations affecting new product design and implementationStrong working knowledge of GMPs and FDA/ISO guidelines for manufacturing of Food, Supplement productsStrong analytical and critical thinking skillsStrong attention to detailStrong interpersonal and communication skillsPrior experience managing and developing othersAbility to represent the company needs when dealing with suppliers, contact manufacturers, regulatory agencies, and other departments within the corporationTypical hybrid office environment with flexibility for industry events and up to 40% travel for supplier visits
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