Director of Quality

W. S. Badger • Full-time • Gilsum, NH, US • 8h ago

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.

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 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

Quality Systems & FDA Compliance Oversight-

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

Cross-Functional Partnership & Operational Integration-

Partners closely with the Director of Operations to balance compliance requirements 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 Responsibilities-

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, and capability-building within the Quality organization
Coaches' managers and supervisors on effective, inspection-ready communication during audits, investigations, and cross-functional interactions
Resolves complex cross-functional conflicts and facilitates consensus among diverse stakeholders
Makes critical independent determinations regarding product quality, compliance risk, and product disposition
Balances multiple departmental and organizational priorities while maintaining regulatory compliance and quality integrity
Fosters inclusive team environments by actively seeking diverse perspectives during discussions and decision-making processes

Pay starting at $120,000; salary is commensurate to experience.

Requirements

Education 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 environment
Minimum 5 years of direct people management experience, including ownership of supervisors or managers within a regulated manufacturing environment
Demonstrated experience leading FDA inspections and managing responses to regulatory observations
Deep understanding of FDA regulatory requirements for OTC drugs and cosmetics
Strong working knowledge of cGMP, 21 CFR 210/211, OTC drug monographs, validation requirements, and ISO standards
Proven success overseeing and continuously improving Quality Management Systems in a regulated manufacturing environment
Audit-level written and verbal communication skills, with the ability to represent the organization effectively in regulatory and executive settings
Strong cross-functional collaboration, project management, budgetary, and analytical skills
Experience with ERP/MRP systems and electronic quality management systems

Physical Requirements:

Physical requirements for the job include but are not limited to prolonged periods sitting at a desk and working on a computer. Must be able to lift up to 15 pounds times. Employees should be able to perform the essential functions of the job with or without reasonable accommodations. 

EEO Statement:

W.S Badger Company, Inc. is an equal opportunity employer, dedicated to the policy of non-discrimination in employment on any basis including race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family history), political affiliation, military service, marital status, hair texture or types, or other non-merit-based factors.

Benefits