Director of Quality & Regulatory

Position Purpose and Objectives

The Director of Quality & Regulatory leads and manages all Quality and Regulatory functions for Celmark Labs across topical, ingestible, and OTC product categories. This role ensures regulatory compliance, operational excellence, and continuous improvement while fostering a strong Quality culture throughout the organization.

Essential Job Functions

- Provide leadership and oversight for all areas of the Quality Department, including:

- Quality Assurance (QA)

- Quality Control (QC)

- QC Laboratory

- Regulatory Affairs

- Training & Compliance

- Ensure Quality best practices for topical, ingestible, and OTC products, emphasizing continuous improvement, risk mitigation, and adherence to applicable cGMP standards.

- Lead and host all regulatory, accreditation, and customer inspections and audits.

- Ensure full company compliance with all relevant State and Federal regulations, including those covering dietary supplements, cosmetics/topicals, and OTC drug products.

- Obtain, maintain, and ensure compliance with external certifications, including:

- NSF

- Organic

- NEST

- Kosher

- Halal

- Additional certifying bodies as required

- Drive ongoing Quality culture improvements through training, system development, and strong quality leadership.

- Provide regulatory guidance and customer support, including label review, claims evaluation, and regulatory interpretation for all product types.

- Ensure strict compliance with internal SOPs and cGMP across all manufacturing and operational processes.

Knowledge, Skills, and Abilities Required

- Strong decision-making and analytical capabilities.

- Project management skills.

- Effective problem-solving and conflict-resolution abilities.

- Demonstrated leadership and team development experience.

- Deep understanding of cGMP, Quality Systems, FDA regulations, and industry standards for ingestible products, dietary supplements, cosmetics/topicals, and OTC products.

- High integrity and professional ethics.

Supervisory Responsibility

- Quality Departments.

Working Conditions

- Facility wide including warehouse, shipping, receiving, manufacturing, packaging, and QC labs.

Minimum Qualifications

- Bachelor’s degree (B.S.) required; advanced degree preferred.

- Minimum 10 years of progressive Quality leadership experience within ingestible (dietary supplements), topical/cosmetic manufacturing, and/or OTC product manufacturing.

- Must meet departmental cGMP and SOP requirements.

- Additional certifications (e.g., HACCP, PCQI, Regulatory Affairs) preferred.

Success Factors

- Driven and motivated.

- Intelligent and displays aptitude.

- Willingness to cooperate and work with other departments.

- Insight and forethought into management of subordinates.

- Ability to manage and work with a variety of characters and personnel.

- Excellent interpersonal communication skills.