Commercial Quality Systems Lead: US Product Release & Compliance

Galderma S.A.; Miami (FL); On-site; USD 85,000 - 106,000; Full time

Job summary

Galderma S.A. in Miami seeks a Senior Specialist, Commercial Quality Systems to lead the quality review, disposition, and release of Rx, OTC, and Cosmetic products for the U.S.

market, ensuring compliance with FDA regulations and internal quality standards. The role collaborates with contract manufacturers, laboratories, distributors, and internal teams to manage deviations, investigations, CAPAs, change controls, and document control.

Qualifications

• Bachelor's degree in life sciences or related field required.
• Minimum of eight years of progressive quality assurance/system/compliance experience in regulated industries.
• Experience reviewing/approving quality records and supporting product release activities.
• Experience with electronic Quality Management Systems (eQMS) and working with external manufacturers/suppliers.

Responsibilities

• Perform quality review and approval of commercial product release packages for Rx, OTC, and Cosmetics products.
• Evaluate deviations, investigations, CAPAs, and other quality events for product disposition decisions.
• Support QMS processes, including deviations, investigations, CAPA, change control, document control, and training compliance.
• Support supplier quality management and audits; collaborate with cross-functional teams to ensure supplier compliance.
• Assist in investigations of product quality complaints and market quality activities, including recalls when necessary.

Skills

Strong analytical

Problem solving

Communication

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's Degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering, or related discipline

Tools

Veeva

TrackWise

MasterControl

SAP

Job description

Galderma S.A. in Miami seeks a Senior Specialist, Commercial Quality Systems to lead the quality review, disposition, and release of Rx, OTC, and Cosmetic products for the U.S.

market, ensuring compliance with FDA regulations and internal quality standards. The role collaborates with contract manufacturers, laboratories, distributors, and internal teams to manage deviations, investigations, CAPAs, change controls, and document control.