Director of Quality

Job Title: Director of Quality

Location: Gilsum, NH

Position Overview

The Director of Quality leads the Quality Unit in alignment with the company’s mission and principles. This role is accountable for enterprise-wide quality governance, FDA regulatory compliance, and continuous improvement of the Quality Management System (QMS). The position ensures that all quality systems and manufacturing operations comply with FDA regulations, cGMP standards, and internal requirements across formulation, manufacturing, filling, packaging, warehousing, and supply chain functions.

This role works closely with the Director of Operations and RDI leadership to support regulatory readiness and certification requirements, while maintaining independent authority over quality and product disposition decisions.

Key Responsibilities

Quality Leadership & Department Management

• Lead all Quality functions, including Quality Assurance, Quality Control, Validation, and FDA compliance systems, ensuring alignment with business growth objectives and regulatory expectations.
• Develop and execute a quality strategy focused on compliance excellence, risk mitigation, right-first-time performance, and continuous improvement.
• Establish, maintain, and scale an effective Quality Management System (QMS).
• Ensure full compliance of manufacturing operations with FDA regulations, cGMP standards, OTC monographs, and internal quality requirements.
• Partner with the Director of Operations to integrate quality systems across manufacturing, supply chain, and technical operations.
• Collaborate with RDI leadership to support regulatory submissions, certifications (e.g., NOP), and international compliance requirements.
• Define and monitor KPIs related to batch release timelines, deviation trends, CAPA effectiveness, audit readiness, and overall product quality.
• Lead inspection readiness initiatives and serve as the primary Quality representative during FDA inspections and external audits.
• Review and approve FDA responses, corrective action plans, and executive communications related to compliance.
• Communicate quality risks, compliance gaps, and mitigation strategies effectively to executive leadership and cross-functional teams.
• Identify and proactively manage risks impacting product quality, regulatory compliance, or operational continuity.
• Provide oversight of quality systems for contract manufacturers and third-party partners to ensure adherence to regulatory and internal standards.
• Establish and manage Quality Agreements with key suppliers and partners, ensuring clear accountability and performance expectations.
• Oversee departmental budgeting, resource planning, and allocation for the Quality Unit.
• Ensure all quality practices are safe, ethical, legally compliant, and aligned with company values and sustainability initiatives.

Quality Systems & FDA Compliance

• Provide governance and oversight of 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)
• cGMP training systems
• Maintain final authority over product disposition decisions.
• Ensure timely escalation and resolution of quality events impacting compliance.
• Support regulatory and certification initiatives in partnership with RDI.
• Ensure documentation, validation, and manufacturing controls meet regulatory and certification requirements.

Cross-Functional Collaboration & Operational Integration

• Partner with Operations leadership to balance compliance requirements with operational efficiency.
• Drive improvements in right-first-time performance, reduce nonconformances, and enhance process capability.
• Lead cross-functional root cause investigations involving Quality, Operations, and RDI teams.
• Provide Quality oversight for new product launches, ensuring validation, compliance, and inspection readiness.
• Support new product introductions and technical transfers through strong quality system alignment.
• Facilitate clear, structured communication during investigations, audits, and compliance events.
• Provide leadership during high-pressure situations such as regulatory inspections, recalls, and critical quality incidents.
• Represent the Quality function in executive and strategic leadership forums.

People Leadership

• Lead and mentor Quality leadership roles, including QC Supervisor, QA Supervisor, QA Project Manager, and QA Validations Manager.
• Foster a high-performing, collaborative, and mission-driven team culture.
• Drive employee development, succession planning, and capability building within the Quality organization.
• Manage performance processes, including onboarding, ongoing evaluations, and complex employee relations in partnership with HR.
• Coach leaders on effective communication during audits, investigations, and cross-functional activities.
• Resolve cross-functional conflicts and facilitate alignment across stakeholders.
• Make independent, critical decisions regarding product quality, compliance risk, and product disposition.
• Promote inclusive leadership by encouraging diverse perspectives in decision-making.

Qualifications

Education & Experience

• Bachelor’s degree in Chemistry, Microbiology, Engineering, Pharmaceutical Sciences, or a related field (advanced degree preferred).
• 7–10+ years of progressive Quality leadership experience within a regulated OTC manufacturing environment.
• Minimum 5 years of direct people management experience, including oversight of supervisors or managers.
• Proven experience leading FDA inspections and managing regulatory responses.
• Strong knowledge of FDA regulations for OTC drugs and cosmetics.
• In-depth understanding of cGMP, 21 CFR 210/211, OTC monographs, validation requirements, and ISO standards.
• Demonstrated success in managing and improving Quality Management Systems in regulated environments.

Skills & Competencies

• Exceptional written and verbal communication skills, with the ability to represent the organization in regulatory and executive settings.
• Strong cross-functional collaboration, project management, analytical, and budgeting skills.
• Experience with ERP/MRP systems and electronic Quality Management Systems (eQMS).