Overview

Job DescriptionJob DescriptionAbout the RoleCTK OTC Laboratories is seeking an experienced Director of QA to serve as the head of our QA Unit. In this role, you will hold ultimate authority and responsibility for the quality systems governing the manufacture, testing, and release of OTC monograph drug and cosmetic products. Reporting directly to the CEO/President, you will set QA/QC strategy, make final decisions on product disposition and batch release, lead the response to regulatory inspections (FDA/MFDS and other authorities), and safeguard the independence of the Quality Unit as required under 21 CFR 211.22.You will lead and develop the entire Quality organization - through the QA Manager and QC Manager - and own the department's budget, staffing plan, and quality performance objectives.What You'll DoEstablish and maintain the site quality strategy, quality policy, and quality objectives, ensuring the Quality Unit operates independently of Production (21 CFR 211.22)Exercise final approval authority for release or rejection of OTC drug product batches, including reprocessing and returned/recalled goods dispositionProvide final approval of product specifications, expiration dating, and Annual Product Review (APR) reportsDirect the site's response to regulatory and customer inspections and audits (FDA, MFDS, state, and third-party), owning preparation, hosting, response letters, and commitment closureApprove product recalls, market withdrawals, and related regulatory reporting (e.g., Field Alert Reports)Oversee the Quality Management System - Deviations, OOS/OOT investigations, CAPA, Change Control, Internal Audit, complaint handling, and management reviewApprove supplier and contract-laboratory qualification, approved-vendor status, and quality agreementsOwn the validation master plan and approve process, cleaning, equipment, analytical method, and computer system (Part 11/CSV) validation strategiesEnsure training programs, data integrity (ALCOA+) controls, and documentation systems keep the site inspection-ready at all timesManage the Quality Department's budget, headcount plan, capital requests, and organizational structureRepresent the Quality Department to executive management, customers, and regulatory authoritiesLeadership ResponsibilitiesDirectly supervise the QA Manager and QC Manager, with indirect oversight of the full Quality Department (QA Associate, Document Control, QC Laboratory Technicians, Package Incoming Inspector, and Microbiology Laboratory personnel)Define departmental structure, reporting lines, and delegation of authorityLead recruiting, hiring, and onboarding of QA/QC personnel alongside Human ResourcesSet goals, conduct performance evaluations, and guide compensation and promotion recommendationsEnsure all personnel meet training and qualification requirements under 21 CFR 211.25Build a strong quality culture where employees are empowered to report deviations, OOS results, and data-integrity concerns without fear of reprisalEducation & ExperienceBachelor's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, Biology, Chemical Engineering, or a related scientific discipline (Master's degree or Pharm.D. preferred)Minimum 10 years of experience in a Quality Unit (QA and/or QC) within a cGMP drug manufacturing facilityAt least 5 of those years in a Quality management or supervisory role (Manager level or higher) with direct personnel responsibilityDocumented experience hosting and responding to FDA (and MFDS or other health-authority) inspectionsOTC monograph drug and/or cosmetic manufacturing experience strongly preferredExperience with final batch release/disposition authority, recall execution, and Annual Product Review approval preferredProfessional certification (e.g., ASQ CQA/CQM, RAC) is a plusKnowledge, Skills & AbilitiesExpert knowledge of cGMP regulations (21 CFR Parts 210, 211), 21 CFR Part 11, and applicable OTC monograph, labeling (Drug Facts), and cosmetic (MoCRA) require