Quality Director: cGMP, FDA Compliance Leader

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

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.