Director of Quality Laboratories

The Director of Quality Laboratories is responsible for ensuring all laboratory quality activities are performed in accordance with PakLab’s Quality Program, cGMP, ISO standards, and all applicable regulatory requirements. This leader will provide strong direction, oversight, and mentorship to Quality Laboratory teams across PakLab sites, ensuring compliant operations, efficient testing processes, and alignment with corporate goals. The role requires strategic leadership, hands-on expertise, and the ability to operate effectively within a dynamic, regulated manufacturing environment for cosmetic and OTC drug products.

Key Qualifications & Competencies

• 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.

Essential Duties & Responsibilities

Regulatory & Quality Systems Leadership

• 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.

Laboratory Operations Management

• 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.

Customer, Supplier & Cross-Functional Collaboration

• 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.

Leadership, People Management & Development

• Recruit, train, evaluate, coach, and discipline Quality Laboratory personnel.
• Establish department goals and ensure alignment with corporate quality objectives.
• Educate laboratory personnel on customer, regulatory, and third-party requirements.
• Provide leadership and strategic input as a member of the Quality Management Team.

Continuous Improvement & Strategic Initiatives

• Lead laboratory process improvements, efficiency initiatives, and quality system enhancements.
• Ensure support for statistical analysis, quality planning, inspection processes, root cause analysis, and continuous improvement methodologies.
• Implement approved reporting, sampling, and data analysis activities.
• Manage and maintain the Quality Laboratory budget, licenses, and fiscal responsibilities.

Other Responsibilities

• Attend relevant conferences, audits, and training seminars as needed.
• Support compliance with all company policies, safety regulations, and PPE requirements.
• Perform additional duties as assigned by the Head of Quality & Regulatory.

Physical Requirements

• Ability to lift/pull at least 40 lbs.
• Requires prolonged standing, walking, and sitting.
• Must be able to bend, pull, push, reach, climb stairs, and navigate laboratory and production environments.
• Use of PPE (safety glasses, lab coats, etc.) is required in designated areas.
• Approximately 10% travel for vendor certifications, customer visits, and related assignments.

Education & Experience Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry, Mathematics, or related field required.
• Master of Science or MBA preferred.
• Minimum 10 years of OTC drug experience, including 5 years of supervisory experience.
• Minimum 5 years of quality management experience.
• Strong working knowledge of FDA regulations, cGMP, validation processes, and quality systems.
• Proven experience leading regulatory, customer, and third-party audits.
• Excellent written and verbal communication skills.

Supervisory Responsibilities

• Direct supervision of Quality Laboratory personnel, including staff development, performance evaluations, coaching, and disciplinary actions.

Fiscal Responsibilities

• Responsible for laboratory budgets, department spending, and related licenses.