GMP Quality & Compliance Leader

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 180,000 - 230,000; 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 Systems, ensuring compliance with FDA and State boards and maintaining product quality across QA and QC functions.

Responsibilities include managing inspections, deviations, CAPAs, training, audits, and regulatory submissions, while guiding a team of quality professionals in a fast-paced sterile manufacturing environment.

Qualifications

• BS or PharmD required; advanced degree preferred.
• Minimum 10 years in related QA/QC or quality leadership roles.
• Experience with sterile drug manufacturing and 503B operations.

Responsibilities

• Oversee QA/QC activities to ensure compliance with FDA and state boards.
• Lead quality system maintenance, deviations, CAPAs, change controls, and investigations.
• Manage annual product quality reporting and regulatory inspections.
• Coordinate training and personnel development for quality staff.

Skills

Leadership

Quality systems

Regulatory awareness

Communication

Education

BS or PharmD

Tools

GMP/ISO 14644

Job description

Fagron Sterile Services US (FSS) in Wichita, KS seeks a Quality Site Head to lead the 503B outsourcing facility's Quality Systems, ensuring compliance with FDA and State boards and maintaining product quality across QA and QC functions.

Responsibilities include managing inspections, deviations, CAPAs, training, audits, and regulatory submissions, while guiding a team of quality professionals in a fast-paced sterile manufacturing environment.