Quality Director

Sombra USA; Albuquerque (NM); Hybrid; USD 130,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Vision insurance

Job summary

Sombra Cosmetics in Albuquerque, NM seeks a Director of Quality to lead QA and compliance at our FDA-registered, cGMP-compliant facility. This hands-on leadership role ensures every material and product meets our safety and efficacy standards.

The ideal candidate will have deep knowledge of FDA/cGMP regulations in cosmetic or OTC topical spaces, strong people leadership, and a collaborative approach to continuous improvement in a small manufacturing setting.

Qualifications

• Bachelor's degree in chemistry, engineering, or related field.
• 5+ years in quality role in FDA-regulated setting.
• Experience in OTC or pharmaceutical manufacturing is a big plus.
• Comfortable using Microsoft Office and working with quality documentation systems.

Responsibilities

• Oversee all quality operations from raw materials to finished products.
• Lead a small quality team and ensure regulatory compliance (FDA, cGMP, OSHA).
• Review and approve batch records, lab reports, and test results.
• Monitor production processes and ensure compliance with internal standards.
• Handle inspections, audits, and compliance reporting.
• Collaborate with production and leadership to improve processes.
• Train team members in quality and compliance practices.
• Maintain and enhance quality systems (CAPA, deviation, non-conformance, change control, SOPs).

Skills

Quality systems

FDA/cGMP regulations

Team leadership

Documentation control

Problem solving

Communication skills

Education

Bachelor's in Chemistry/Engineering

Tools

MS Office

QMS tools

Job description

Company Overview
Sombra Cosmetics is dedicated to producing high-quality, OTC pain-relieving products that prioritize quality and reliability. With over 50 years of experience, our commitment to our high standards makes us a trusted leader in the industry among health care providers and their patients.

Job description:
Director of Quality
Full-time | On-site | Small OTC Manufacturing Company

We are seeking an experienced and driven Quality Director 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 products.
• 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 in 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.
• Flexible work environment with a collaborative team.
• Opportunity to make a big impact on a small company.
• Room to grow as the company grows.
• Health insurance
• Paid time off
• Vision insurance

*Equal Opportunity Employer