Director of Quality & Regulatory Compliance

Full-time | On-site | Small OTC Manufacturing Company

We are seeking an experienced and driven Director of Quality & Regulatory Compliance to lead our quality assurance and compliance efforts at our FDA-registered, cGMP-compliant facility. This is a hands-on leadership role responsible for ensuring that all products—from raw materials to finished goods—adhere to Sombra’s high standards of safety, integrity, and effectiveness. Ideal candidates will have a deep understanding of cGMP requirements in the cosmetic or OTC topical space and thrive in a dynamic, collaborative manufacturing environment.

What You’ll Do:

  • Oversee all quality operations, from raw materials to finished product.
  • Lead a small quality team and make sure we’re staying on track with regulations (FDA, cGMP, OSHA, etc.).
  • Review and approve documentation like batch records, lab reports, and test results.
  • Monitor production processes and make sure everything meets internal standards.
  • Handle inspections, audits, and compliance reporting.
  • Work closely with production and leadership to troubleshoot and improve processes.
  • Train team members on quality and compliance practices.
  • Maintain and enhance quality systems (CAPA, deviation, non-conformance, change control, SOP development and revision, training, documentation, etc.).

What We’re Looking For:

  • A solid understanding of quality systems and FDA/cGMP regulations.
  • Someone who’s organized, detail-oriented, and great at solving problems.
  • A natural leader who’s comfortable managing a team and making decisions.
  • Strong communication skills—you’ll work closely with everyone from the production floor to the executive team.

Qualifications:

  • Bachelor’s degree in Chemistry, Engineering, or a related field.
  • 5+ years of experience in a quality role, preferably in an FDA-regulated setting.
  • Experience in OTC or pharmaceutical manufacturing is a big plus.
  • Comfortable using Microsoft Office and working with quality documentation systems.

Bonus Points If You:

  • Like being part of a small, tight-knit team.
  • Enjoy improving processes and finding better ways to do things.
  • Can switch between strategy and day-to-day tasks with ease.

Perks:

  • Flexible work environment with a collaborative team.
  • Opportunity to make a big impact in a small company.
  • Room to grow as the company grows.