Director of Quality Laboratories

The Director of Quality Laboratories is responsible for ensuring all laboratory quality activities are performed in accordance with Pak Lab’s Quality Program, cGMP, ISO standards, and all applicable regulatory requirements.

In this role, you will lead and manage a team of 20+ professionals across Micro, Analytical, QC, and Stability laboratories. Responsible for Environmental Monitoring, Product Testing, Product Suitability, and Stability functions, ensuring full compliance with GLP, GMP, GDP and other applicable regulatory requirements for OTC and Cosmetic manufacturer. Direct all stability testing activities in alignment with ICH guidelines, including review and approval of protocols, documentation, and results.

Establish and maintain a comprehensive microbiological suitability program, completing product suitability studies to verify methods against applicable standards. Maintain calibration and IQ/OQ/PQ programs for laboratory equipment and instrumentation. Oversaw laboratory workflows to ensure timely execution of testing, and collaborate cross-functionally with R&D, Operations teams meet customer requirements. Led laboratory investigations including OOS, OOT, and environmental excursions, support & perform internal audits to ensure GxP and safety compliance.

Author and approve SOPs and monitor KPIs for operational efficiency. Execute investigations with CAPA support, and perform comprehensive gap analyses against USP, ISO, and other applicable laboratory standards.

• Excellent attendance and punctuality.
• Ability to work any shift as business needs require.
• Demonstrated critical thinking, leadership, and team development skills.
• Ability to work independently and collaboratively with internal teams, customers, suppliers, and regulatory agencies.
• Strong analytical skills with the ability to interpret technical, statistical, project management, and regulatory documentation.
• Experience with manufacturing and laboratory operations, quality assurance principles, and their impact on product release and compliance.
• Hands‑on experience with regulatory, third‑party, and customer audits.
• Strong organizational, prioritization, and time‑management skills; ability to manage multiple assignments.
• Ability to guide, supervise, train, and counsel laboratory staff.
• Understanding of health, beauty, pharmaceutical/OTC, and environmental regulations.
• Flexible and able to shift tasks without losing accuracy or efficiency.

• Interpret, implement, and integrate regulatory requirements for cosmetic and OTC product manufacturing.
• Ensure laboratory processes comply with cGMP, ISO standards, and federal regulations.
• Develop and maintain QA and laboratory standards, including specifications, testing requirements, and documentation.
• Maintain the OTC Master Drug List.
• Provide guidance to internal stakeholders regarding regulatory positions and company compliance strategies.

• Oversee development, implementation, and continuous improvement of laboratory systems, testing processes, and quality controls.
• Direct daily laboratory operations to ensure timely testing and product release for raw materials, in‑process products, and finished goods.
• Evaluate, analyze, and define inspection and sampling requirements for validation and production release.
• Review laboratory notebooks, CoAs, OOS investigations, SOPs, specifications, BOMs, and validation documentation.
• Maintain systems to measure laboratory performance against defined quality standards.
• Ensure consistent communication and direction to lab teams regarding quality issues.

• Serve as the primary point of contact for customer, supplier, and regulatory communications related to laboratory quality.
• Respond to customer, third‑party, and regulatory deficiencies in a timely and accurate manner.
• Determine, review, and approve supplier performance per laboratory requirements.
• Support internal and external customers in relation to release timelines, testing turnaround, and compliance expectations.

• Recruit, train,…