QA & Compliance Director, 503B Facility

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 180,000 - 240,000; Full time

Job summary

Fagron Sterile Services US (FSS) in Wichita, KS, seeks a Quality Site Head to lead the 503B outsourcing facility's Quality System and regulatory readiness. You will guide QA/QC, calibration, investigations and training to ensure product quality and compliance.

The role involves directing management reviews, handling FDA inspections, CAPAs and audits, and driving continuous improvement across cGMP operations and quality metrics within a large sterile manufacturing site.

Qualifications

• Bachelor's degree in science or pharmacy is required.
• 10+ years of related work experience with at least 5 years in management of QA/QC.
• Experience with FDA audits and ISO/ GMP regulatory requirements.

Responsibilities

• Oversee QA and QC for the 503B facility, including material disposition and final product release.
• Lead regulatory inspections, audits, and management reviews.
• Drive CAPAs, deviations, investigations and change controls to closure.
• Develop staff through training, workload planning and performance management.
• Ensure compliance with cGMP, FDA, and state board requirements.

Skills

Leadership

Budget planning

Regulatory liaison

Quality systems

Team development

Education

Bachelor of Science or Bachelor of Pharmacy

Job description

Fagron Sterile Services US (FSS) in Wichita, KS, seeks a Quality Site Head to lead the 503B outsourcing facility's Quality System and regulatory readiness. You will guide QA/QC, calibration, investigations and training to ensure product quality and compliance.

The role involves directing management reviews, handling FDA inspections, CAPAs and audits, and driving continuous improvement across cGMP operations and quality metrics within a large sterile manufacturing site.