QA Leader: QMS & Regulatory Compliance (Cosmetics/OTC)

Prime Matter Labs; New York (NY); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Prime Matter Labs in New York City seeks a Quality Assurance Supervisor to lead the QMS and ensure cosmetic and OTC products meet FDA regulations, cGMPs, and ISO standards. This role provides QA oversight for manufacturing operations and supports regulatory inspections.

You will mentor the QA team, manage deviations, CAPAs, change controls, audits, and training, and collaborate with Operations to maintain GMP compliance and product quality across packaging, labeling, and warehouse functions.

Qualifications

• 5+ years of QA experience in cosmetics, OTC, pharmaceutical, or regulated manufacturing.
• Prior QA leadership or supervisory experience.
• Strong knowledge of FDA regulations, cGMPs, and cosmetic/OTC compliance.

Responsibilities

• Develop, implement, and maintain the QMS in accordance with FDA, cGMP, and ISO requirements.
• Oversee deviations, CAPAs, change controls, and root cause investigations.
• Ensure effective document control and approval of quality-related records.
• Establish and monitor quality metrics to assess compliance and performance.
• Lead and support FDA inspections, customer audits, and third-party audits.
• Prepare audit responses and ensure timely closure of observations.
• Maintain inspection readiness and support regulatory submissions as needed.
• Provide QA oversight of manufacturing, packaging, labeling, and warehouse operations.
• Partner with Operations and related functions to ensure GMP compliance and product quality.
• Support validation, supplier quality, and material qualification activities.
• Lead, mentor, and develop the QA team.
• Ensure GMP and quality training programs are implemented and maintained.
• Promote a culture of quality, accountability, and continuous improvement.
• Serve as a primary quality contact for customers.
• Manage customer complaints and drive effective investigations and corrective actions.

Skills

QA leadership

FDA regulations

cGMPs

Quality management

Communication

Problem-solving

Education

Bachelor's degree in a scientific or related field

Job description

Prime Matter Labs in New York City seeks a Quality Assurance Supervisor to lead the QMS and ensure cosmetic and OTC products meet FDA regulations, cGMPs, and ISO standards. This role provides QA oversight for manufacturing operations and supports regulatory inspections.

You will mentor the QA team, manage deviations, CAPAs, change controls, audits, and training, and collaborate with Operations to maintain GMP compliance and product quality across packaging, labeling, and warehouse functions.