GCP Compliance Manager, Quality & Regulatory

Alcon; Johns Creek (GA); Presencial; USD 111.000 - 143.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Robust benefits package

Descripción de la vacante

Alcon is seeking a Manager, Good Clinical Practices to lead GCP compliance efforts within the QA Compliance Team. The role covers audits, CAPA, and ensuring adherence to GCP/GLP standards across multiple sites in the U.S. and globally.

The candidate will drive regulatory alignment, SOP maintenance, and continuous improvement, contributing to high-quality clinical activities and patient safety.

Formación

• The ability to fluently read, write, understand and communicate in English.

Responsabilidades

• Lead compliance activities for Good Clinical Practices (GCP) and drive quality improvement projects.
• Manage external audits and ensure site preparedness for inspections.
• Coordinate CAPA processes and resolution of quality issues.
• Oversee SOP creation, revision, and adherence across studies, facilities, and suppliers.
• Perform audits/inspections of processes and documents to ensure GCP/GLP regulatory compliance.
• Coordinate internal and external audits/regulatory inspections and drive ongoing CAPA execution.
• Lead implementation of new regulations and regulatory guidance in line with GxP standards.

Conocimientos

English fluency

Educación

Bachelor's Degree

Descripción del empleo

Alcon is seeking a Manager, Good Clinical Practices to lead GCP compliance efforts within the QA Compliance Team. The role covers audits, CAPA, and ensuring adherence to GCP/GLP standards across multiple sites in the U.S. and globally.

The candidate will drive regulatory alignment, SOP maintenance, and continuous improvement, contributing to high-quality clinical activities and patient safety.