Director of Quality

Overview

We are seeking a seasoned and solutions-oriented Quality Director to lead the evolution and expansion of our Quality division. This is a high-impact leadership role ideal for someone who thrives in fast-paced, scaling manufacturing environments and brings a proactive, process-driven approach to quality assurance, compliance, and continuous improvement.

This individual will be instrumental in building and optimizing a best-in-class quality system that ensures product integrity, regulatory compliance, and client satisfaction. The ideal candidate is both strategic and hands-oncapable of setting the vision while also rolling up their sleeves to implement it.

Base pay range

$135,000.00/yr - $150,000.00/yr

Responsibilities

• Provide leadership and guidance to the quality assurance and quality control teams, fostering a culture of accountability and continuous improvement.
• Partner with functional/business units to design and improve effectiveness and efficiency quality systems by implementing process enhancement, operational improvements, organizational effectiveness, technical solutions, and audit readiness.
• Own the development and execution of validation processes (equipment, process, cleaning, etc.) and ensure timely reporting of nonconformances, root cause analyses, and trending of quality metrics.
• Interpret quality control results and provide clear, actionable feedback to production teams.
• Support new product development and tech transfers with risk-based quality input and documentation.
• Supervise the collection and analysis of production samples to ensure quality standards are met.
• Train and mentor team members across all levels to elevate quality understanding and ownership across the organization.
• Standardize and maintain GMP-compliant SOPs, documentation, and internal processes to support audit readiness and traceability.
• Track, analyze, and report on quality performance metrics to drive transparency and continuous improvement.
• Lead preparation for and response to third-party, regulatory, and client audits; ensure readiness and compliance with cGMP, FDA 21 CFR Parts 210/211, OTC Monograph System, ISO 9001, ISO 22716, ICH Guidelines, NSF 455-3/455-4 standards.
• Maintain awareness of internal and external trends, opportunities for improvement, new customers, changes in markets, new industry developments, evolution of standards and industry practices, threats and risk to the organization.

Qualifications

• 810 years of progressive experience in quality management within contract manufacturing, beauty/personal care, or OTC regulated environments with at least 3 years in a leadership role.
• Bachelors degree in a scientific or engineering discipline required; advanced degree or certifications (e.g., ASQ CQE, CQA, or CMQ/OE) preferred.
• Strong understanding of FDA 21 CFR 210/211, OTC monograph system, cosmetic regulations, and quality standards (ISO 22716, ISO 9001).
• Strong attention to detail and organizational skills, with the ability to manage multiple projects and deadlines effectively.
• Excellent written and verbal communication skills, with the ability to communicate complex quality concepts clearly and effectively.
• Advanced skills in documentation control, SOP development, and root cause analysis.
• Proficient in ERP systems, QMS platforms, document management systems, and standard productivity tools (Microsoft Office/Google Workspace).

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing and Personal Care Product Manufacturing

Benefits

• Medical insurance
• Vision insurance
• 401(k)

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