Director of Quality

Director of Quality | Quality Assurance & Control Lead and oversee all quality operations within a pharmaceutical manufacturing environment by developing, implementing, and maintaining a cGMP-compliant quality system aligned with regulatory standards, customer requirements, and industry best practices. Role Overview Responsible for establishing and maintaining a cGMP Quality Management System in compliance with 21 CFR regulations and U.S. Food and Drug Administration standards. The role ensures product quality, regulatory compliance, and continuous process improvement while leading quality teams and supporting organizational objectives. Leadership & OversightManage Quality Assurance, Quality Control, and laboratory operationsSupervise QA Manager, QC Manager, Lab Supervisor, Chemists, QA Associates, and Microbiology staffRecruit, train, and develop team membersProvide performance feedback and manage disciplinary actions Key ResponsibilitiesEstablish and maintain the Quality Management System and ensure ongoing cGMP complianceAudit quality processes, policies, and procedures to maintain operational controlDevelop and enforce procedures, protocols, and specifications, including third-party oversightImplement and monitor manufacturing in-process controlsReview and approve/reject cGMP documentation, batch records, and product release decisionsLead investigations of deviations, nonconformance, and customer complaints with root cause analysisReport quality risks, system performance, and regulatory inspection outcomes to leadershipMaintain independence in quality review and approval activities Required SkillsStrong communication, leadership, and teamwork abilitiesExcellent organizational and time management skillsKnowledge of quality systems, including change control, deviations, and CAPA processesAbility to manage multiple priorities in fast-paced environmentsProficiency in SOP development, documentation, and reporting Education & ExperienceBachelor's degree in Chemistry, Biology, or a related field10+ years of management experience in pharmaceutical manufacturingExpert knowledge of cGMP and regulatory requirementsExperience with Microsoft applications and quality documentation systemsPharmaceutical industry experience required Work Requirements Ability to sit, stand, or walk for extended periods (8+ hours daily)