Quality Site Head: GMP & FDA Compliance Leader

Fagron Nederland BV; Wichita (KS); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Life Insurance

Paid Holidays

Paid Volunteer Time

Paid Time Off & Rollover

401K & Retirement Plans

Employee Assistance Program

Flexible working arrangements

Job summary

Fagron US in Wichita, KS, seeks a Quality Site Head for its 503B outsourcing facility of about 600 personnel. You will lead the maintenance and improvement of Quality Systems to ensure FDA and Board of Pharmacy compliance and oversee QA, QC, training, and regulatory activities.

You will direct investigations, CAPAs, deviations, and audits, manage budgets and resources, and drive continuous improvement across incoming materials, testing, equipment, and environmental monitoring.

Qualifications

• BS or PharmD required; advanced degree preferred.
• Minimum 10 years in relevant roles including 5+ years in management.
• Strong GMP/QA/QC understanding in sterile pharmaceutical manufacturing.
• Experience with FDA audits and compliance leadership.
• Knowledge of cGMP and ISO 14644 standards.
• Experience leading inspections and regulatory processes.

Responsibilities

• Oversee QA and QC activities, including release, investigations, and CAPAs.
• Lead regulatory inspections and customer audits, providing documentation and responses.
• Manage training, equipment validation, environmental monitoring, and deviations.
• Direct monthly/quarterly metrics review and quality reporting.
• Coordinate with regulatory bodies and site management on Quality systems.

Skills

Leadership

Attention to detail

Regulatory liaison

Communication

Decision making

Education

Bachelor of Science

Pharmacist degree

Tools

GMP knowledge

Job description

Fagron US in Wichita, KS, seeks a Quality Site Head for its 503B outsourcing facility of about 600 personnel. You will lead the maintenance and improvement of Quality Systems to ensure FDA and Board of Pharmacy compliance and oversee QA, QC, training, and regulatory activities.

You will direct investigations, CAPAs, deviations, and audits, manage budgets and resources, and drive continuous improvement across incoming materials, testing, equipment, and environmental monitoring.