Quality Site Leader

EPTA•Columbus, GA

6d•Remote

About The Position

The Quality Leader is responsible for overseeing and ensuring the adherence to quality management systems, regulatory requirements, and compliance standards across all manufacturing sites within the assigned country. This role leads the development and implementation of site-specific quality policies, procedures, and practices to ensure that all operations align with corporate quality objectives, industry regulations, and customer requirements.

Requirements

5+ years of experience in quality management and regulatory compliance within manufacturing or similar industries
Proven expertise in managing site-specific quality systems, regulatory audits, and compliance programs across multiple locations.
Bachelor’s or Master’s degree in Quality Management, Industrial Engineering, or a related field.

Responsibilities

Lead and ensure the compliance of manufacturing sites within the country to quality systems, regulatory requirements, and internal policies.
Develop, implement, and maintain site-specific quality systems and ensure they are aligned with corporate standards and regulatory requirements.
Coordinate and lead regulatory audits, including internal audits and external inspections by regulatory bodies (e.g., FDA, EMA, ISO certifications).
Provide training and mentoring to site teams on quality management systems, regulatory compliance, and industry best practices.
Prepare and present compliance reports to senior management, highlighting areas of concern, audit results, compliance status, and action plans for continuous improvement.
Lead and oversee risk management activities to identify potential compliance and quality risks at the site level.