Director of Quality

The Director of Quality supports the Badger 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.

• 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 requirements 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.

• Provides governance and oversight for the Quality Management System, including:
• Document control
• Batch record review and release
• Deviation and investigation management
• CAPA systems
• Complaint handling
• Supplier qualification
• Validation programs (process, cleaning, equipment, IQ/OQ/PQ)
• 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.

• Partners closely with the Director of Operations to balance compliance requirements with operational efficiency.
• Collaborates with Operations management to…