Director of Quality

The Director of Quality supports the our Mission and Principles as the head of the Quality Unit. This role is responsible for company-wide quality governance, FDA regulatory compliance, and continuous improvement of the Quality Management System. This position ensures that quality systems and manufacturing operations remain compliant with FDA regulations, cGMP requirements, and internal standards across formulation, manufacturing, filling, packaging, warehousing, and supply chain operations. The Director of Quality partners closely with the Director of Operations and RDI leadership to support regulatory readiness and certification requirements, while maintaining independent authority for quality and product disposition decisions.Essential Responsibilities:Quality Leadership and Department Management -Oversees all Quality functions, including Quality Assurance, Quality Control, Validation, and FDA compliance systems, ensuring alignment with company growth goals and regulatory requirementsDrives quality strategy focused on compliance excellence, risk mitigation, right-first-time performance, and continuous improvementEstablishes and maintains an effective, scalable Quality Management System (QMS)Ensures manufacturing operations comply with FDA regulations, cGMP standards, OTC monographs, and internal quality requirementsPartners with the Director of Operations to ensure smooth integration of quality systems within manufacturing, supply chain, and technical operationsCollaborates with RDI Director to support regulatory submissions, certifications (e.g., NOP), and international requirements by ensuring quality systems and documentation meet applicable standardsEstablishes and monitors KPIs across Quality and in partnership with Operations to track batch release timeliness, deviation trends, CAPA effectiveness, audit readiness, and overall product qualitySpearheads inspection readiness strategy and serves as primary Quality representative during FDA inspections and other audits, as required, confidently representing the organization in high-stakes regulatory interactionsPrepares, reviews, and approves FDA inspection responses, corrective action plans, and executive communications related to compliance mattersCommunicates quality risks, compliance gaps, and mitigation strategies clearly and effectively to executive leadership and cross-functional stakeholdersAnticipates and manages risks that could impact product quality, regulatory standing, or operational continuityProvides executive oversight of Quality systems for contract packagers and third-party manufacturers, ensuring compliance with FDA regulations, cGMP standards, and Badger quality requirementsOwns the development and oversight of all Quality Agreements with critical suppliers, including contract packagers and third-party manufacturers, establishing clear quality accountability, regulatory expectations, performance standards, and risk management requirementsOwns departmental resource planning and budgeting for the Quality UnitEnsures safe, ethical, and legally compliant quality practices consistent with Badger's mission and valuesDrives environmentally responsible quality practices aligned with Badger's sustainability commitmentsQuality Systems & FDA Compliance Oversight-Provides governance and oversight for the Quality Management System, including:Document controlBatch record review and releaseDeviation and investigation managementCAPA systemsComplaint handlingSupplier qualificationValidation programs (process, cleaning, equipment, IQ/OQ/PQ)Training systems related to cGMP complianceMaintains ultimate authority for product disposition decisionsEnsures effective escalation and resolution of quality events that may impact regulatory compliancePartners with RDI on certification and regulatory initiatives to ensure quality system alignmentEnsures documentation, validation, and manufacturing controls support certification audits and regulatory commitmentsCross-Functional Partnership & Operational Integration-Partners closely with the Director of Operations to balance compliance requirements with operational efficiencyCollaborates with Operations management to improve right-first-time performance, reduce nonconformances, and strengthen process capabilityFacilitates cross-functional root cause investigations involving Quality, Operations, and RDIProvides executive Quality oversight for new product launches, ensuring quality system readiness, validation compliance, and inspection preparedness prior to launchSupports new product introductions and technical transfer activities by ensuring quality system readiness and validation complianceFacilitates structured and professional communication between departments during investigations, audit responses, and significant compliance events to ensure alignment and timely resolutionProvides clear, balanced guidance during high-pressure situations, including regulatory inspections, recalls, and significant quality eventsRepresents the Quality Unit in Strategy Team meetings and other company leadership forumsPeople Leadership Responsibilities-Oversees the QC Supervisor, QA Supervisor, QA Project Manager, and QA Validations ManagerModels company mission and principles through day-to-day actions and strategic decisions, setting a standard for ethical, transparent, and purpose-driven directionProvides leadership, training, and guidance to Quality leaders and teams, cultivating a high-performing, collaborative, and mission-aligned workplace cultureUpholds performance management processes, including conducting check-ins for new team members, facilitating Alignment Building Process meetings, managing complex performance issues with HR support, and making exit resolutions for Quality Unit staffDrives employee development, succession planning, and capability-building within the Quality organizationCoaches' managers and supervisors on effective, inspection-ready communication during audits, investigations, and cross-functional interactionsResolves complex cross-functional conflicts and facilitates consensus among diverse stakeholdersMakes critical independent determinations regarding product quality, compliance risk, and product dispositionBalances multiple departmental and organizational priorities while maintaining regulatory compliance and quality integrityFosters inclusive team environments by actively seeking diverse perspectives during discussions and decision-making processesRequirementsEducation and Experience Required:Bachelor's degree in Chemistry, Microbiology, Engineering, Pharmaceutical Sciences, or related technical field (advanced degree preferred)Minimum 7-10 years of progressive Quality leadership experience in a regulated OTC manufacturing environmentMinimum 5 years of direct people management experience, including ownership of supervisors or managers within a regulated manufacturing environmentDemonstrated experience leading FDA inspections and managing responses to regulatory observationsDeep understanding of FDA regulatory requirements for OTC drugs and cosmeticsStrong working knowledge of cGMP, 21 CFR 210/211, OTC drug monographs, validation requirements, and ISO standardsProven success overseeing and continuously improving Quality Management Systems in a regulated manufacturing environmentAudit-level written and verbal communication skills, with the ability to represent the organization effectively in regulatory and executive settingsStrong cross-functional collaboration, project management, budgetary, and analytical skillsExperience with ERP/MRP systems and electronic quality management systems