Quality Site Leader – GMP QA/QC Excellence

Fagron Tech; Wichita (KS); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive Salary

Health, Vision, and Dental Insurance

Company Paid Life Insurance

Generous Paid Holidays

Paid Volunteer Time

Generous Paid Time Off and Rollover

Company matching 401K and Retirement

Employee Assistance Program

Flexible working arrangements

Job summary

Fagron US seeks a Quality Site Head for its 503B Outsourcing facility in Wichita, KS. You will oversee the maintenance and improvement of Quality Systems to ensure FDA and state regulatory compliance, manage QA/QC activities, investigations, and change controls to guarantee product quality.

You will supervise training, budget planning, resource management, and regulatory interactions, leading quarterly reviews and audits to maintain high compliance and performance across the site.

Qualifications

• 10+ years of work experience in quality functions.
• Minimum 5 years in a managerial role overseeing QA/QC in a sterile pharmaceutical manufacturing facility.
• Strong understanding of FDA GMP and ISO 14644 requirements.
• Experience with FDA audits and compliance leadership.

Responsibilities

• Oversee all Quality matters at the facility, including disposition of materials and final product, QA/QC testing, deviations, CAPAs and change controls.
• Lead regulatory inspections and customer audits, and coordinate internal/external inspections.
• Manage training, budgets, staff development, and ensure documentation and regulatory compliance.

Skills

Quality Management

Regulatory Audits

People Leadership

GMP/ISO Knowledge

Education

Bachelor of Science or Bachelor of Pharmacy

Advanced degree preferred

Job description

Fagron US seeks a Quality Site Head for its 503B Outsourcing facility in Wichita, KS. You will oversee the maintenance and improvement of Quality Systems to ensure FDA and state regulatory compliance, manage QA/QC activities, investigations, and change controls to guarantee product quality.

You will supervise training, budget planning, resource management, and regulatory interactions, leading quarterly reviews and audits to maintain high compliance and performance across the site.