Director of Quality

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 requirements. · Drives quality strategy focused on compliance excellence, risk mitigation, right-first-time performance, and continuous improvement. · Establishes and maintains an effective, scalable Quality Management System (QMS). · Ensures manufacturing operations comply with FDA regulations, cGMP standards, OTC monographs, and internal quality requirements. · Partners with the Director of Operations to ensure smooth integration of quality systems within manufacturing, supply chain, and technical operations. · Collaborates with RDI Director to support regulatory submissions, certifications (e.g., NOP), and international

by ensuring quality systems and documentation meet applicable standards. · Establishes and monitors KPIs across Quality and in partnership with Operations to track batch release timeliness, deviation trends, CAPA effectiveness, audit readiness, and overall product quality. · Spearheads 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 interactions. · Prepares, reviews, and approves FDA inspection responses, corrective action plans, and executive communications related to compliance matters. · Communicates quality risks, compliance gaps, and mitigation strategies clearly and effectively to executive leadership and cross-functional stakeholders. · Anticipates and manages risks that could impact product quality, regulatory standing, or operational continuity. · Provides executive oversight of Quality systems for contract packagers and third-party manufacturers, ensuring compliance with FDA regulations, cGMP standards, and Badger quality requirements. · Owns 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 requirements. · Owns departmental resource planning and budgeting for the Quality Unit. · Ensures safe, ethical, and legally compliant quality practices consistent with Badger’s mission and values. · Drives environmentally responsible quality practices aligned with Badger’s sustainability commitments. Quality Systems & FDA Compliance Oversight – · Provides governance and oversight for the Quality Management System, including: o Document control o Batch record review and release o Deviation and investigation management o CAPA systems o Complaint handling o Supplier qualification o Validation programs (process, cleaning, equipment, IQ/OQ/PQ) o Training systems related to cGMP compliance · Maintains ultimate authority for product disposition decisions. · Ensures effective escalation and resolution of quality events that may impact regulatory compliance. · Partners with RDI on certification and regulatory initiatives to ensure quality system alignment. · Ensures documentation, validation, and manufacturing controls support certification audits and regulatory commitments. Cross-Functional Partnership & Operational Integration – · Partners closely with the Director of Operations to balance compliance

with operational efficiency. · Collaborates with Operations management to improve right-first-time performance, reduce nonconformances, and strengthen process capability. · Facilitates cross-functional root cause investigations involving Quality, Operations, and RDI. · Provides executive Quality oversight for new product launches, ensuring quality system readiness, validation compliance, and inspection preparedness prior to launch. · Supports new product introductions and technical transfer activities by ensuring quality system readiness and validation compliance. · Facilitates structured and professional communication between departments during investigations, audit responses, and significant compliance events to ensure alignment and timely resolution. · Provides clear, balanced guidance during high-pressure situations, including regulatory inspections, recalls, and significant quality events. · Represents the Quality Unit in Strategy Team meetings and other company leadership forums. People Leadership

– · Oversees the QC Supervisor, QA Supervisor, QA Project Manager, and QA Validations Manager. · Models company mission and principles through day-to-day actions and strategic decisions, setting a standard for ethical, transparent, and purpose-driven direction. · Provides leadership, training, and guidance to Quality leaders and teams, cultivating a high-performing, collaborative, and mission-aligned workplace culture. · Upholds 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 staff. · Drives employee development, succession planning,