About the Role
CTK 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 Do
- Establish 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 disposition
- Provide final approval of product specifications, expiration dating, and Annual Product Review (APR) reports
- Direct the site's response to regulatory and customer inspections and audits (FDA, MFDS, state, and third-party), owning preparation, hosting, response letters, and commitment closure
- Approve 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 review
- Approve supplier and contract-laboratory qualification, approved-vendor status, and quality agreements
- Own the validation master plan and approve process, cleaning, equipment, analytical method, and computer system (Part 11/CSV) validation strategies
- Ensure training programs, data integrity (ALCOA+) controls, and documentation systems keep the site inspection-ready at all times
- Manage the Quality Department's budget, headcount plan, capital requests, and organizational structure
- Represent the Quality Department to executive management, customers, and regulatory authorities
Leadership Responsibilities
- Directly 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 authority
- Lead recruiting, hiring, and onboarding of QA/QC personnel alongside Human Resources
- Set goals, conduct performance evaluations, and guide compensation and promotion recommendations
- Ensure all personnel meet training and qualification requirements under 21 CFR 211.25
- Build a strong quality culture where employees are empowered to report deviations, OOS results, and data-integrity concerns without fear of reprisal
Education & Experience
- Bachelor'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 facility
- At least 5 of those years in a Quality management or supervisory role (Manager level or higher) with direct personnel responsibility
- Documented experience hosting and responding to FDA (and MFDS or other health-authority) inspections
- OTC monograph drug and/or cosmetic manufacturing experience strongly preferred
- Experience with final batch release/disposition authority, recall execution, and Annual Product Review approval preferred
- Professional certification (e.g., ASQ CQA/CQM, RAC) is a plus
Knowledge, Skills & Abilities
- Expert knowledge of cGMP regulations (21 CFR Parts 210, 211), 21 CFR Part 11, and applicable OTC monograph, labeling (Drug Facts), and cosmetic (MoCRA) requirements
- Working knowledge of ICH Q7/Q9/Q10, USP general chapters, and FDA guidance on OOS investigations, process validation, and data integrity
- Proven ability to lead, develop, and retain a multidisciplinary technical organization
- Strong investigational and root-cause analysis skills, with the rigor to challenge weak rationale and enforce documentation standards
- Excellent written and verbal English communication skills, including the ability to author and defend regulatory correspondence and inspection responses
Regulatory Scope
This position serves as the head of the Quality Control Unit as defined under 21 CFR 211.22, with authority to approve or reject all components, containers, closures, in-process materials, packaging materials, labeling, and drug products, and to review production records. The role also supports compliance with personnel qualification (211.25), laboratory controls (211.160–211.167), stability (211.166), records and reports including Annual Product Review (211.180–211.198), returned and salvaged drug products (211.204–211.208), tamper-evident packaging (211.132), and Field Alert/recall reporting obligations.
Benefits
- Medical, dental, and vision insurance — premium 100% covered by employer for the employee
- Paid Time Off (PTO)
- Paid holidays
- Annual floating holiday
