Quality Site Leader

EPTA•Columbus, GA

5d•Remote

About The Position

The Quality Leader oversees adherence to quality management systems, regulatory requirements, and compliance standards across manufacturing sites within the assigned country. The role develops and implements site-specific quality policies, procedures, and practices so operations align with corporate quality objectives, industry regulations, and customer requirements. This role leads compliance management, quality-system oversight, regulatory audits and inspections, training and development, compliance reporting, and site-level risk management. The position is described as permanent. Epta also notes that remote work is possible when feasible, provides necessary technical equipment, and offers flexible working hours.

Requirements

At least 5 years of experience in quality management and regulatory compliance within manufacturing or similar industries.
Proven expertise 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 manufacturing sites within the country comply with quality systems, regulatory requirements, and internal policies.
Develop, implement, and maintain site-specific quality systems aligned with corporate standards and regulatory requirements.
Coordinate and lead regulatory audits, including internal audits and external inspections by regulatory bodies, such as FDA and EMA, and ISO certification audits.
Train and mentor site teams on quality management systems, regulatory compliance, and industry best practices.
Prepare and present compliance reports to senior management, including areas of concern, audit results, compliance status, and continuous-improvement action plans.
Lead and oversee risk-management activities to identify potential site-level compliance and quality risks.