The Director of Quality oversees the company's quality systems to ensure compliance with ISO, GMP, GLP, and FDA standards, with authority to disposition out-of-spec products and halt non-compliant processes. Responsibilities include managing audits, KPIs, and quality metrics; developing and maintaining quality policies; supporting continuous improvement; and managing regulatory requests. They lead the Quality Department, supervise senior staff, and foster a quality-focused culture. Qualifications include a bachelor's degree, 5+ years in regulatory and quality roles, certifications such as ASQ or ISO auditor, and strong leadership skills. Preferred candidates have advanced degrees and extensive QMS knowledge. The role involves office and occasional manufacturing floor work, with travel and possible evening/weekend hours. Strong communication, organizational, and team-building skills are essential.