Quality Site Leader for Sterile Pharma and Compliance

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

Benefits offered by this job

Health Insurance

401K

Flexible working arrangements

Paid Holidays

Paid Time Off

Job summary

Fagron US, a global leader in personalized pharmaceutical solutions, seeks a Quality Site Head for its Wichita, KS facility. You will oversee QA/QC, assure compliance with FDA and state regulations, lead audits, and drive continuous improvement of quality systems and processes.

The role requires robust leadership, extensive GMP knowledge, and a track record of managing quality initiatives in a sterile manufacturing environment. Competitive benefits and opportunities for advancement are offered.

Qualifications

• Bachelor of Science or Bachelor of Pharmacy degree required; advanced degree strongly preferred.
• Extensive GMP/quality systems knowledge and regulatory experience.
• Proven leadership in QA/QC within sterile pharmaceutical manufacturing.

Responsibilities

• Oversee QA and QC operations, including deviations, investigations, CAPAs and change controls.
• Lead FDA/Regulatory inspections and customer audits and ensure timely closure of actions.
• Manage training programs and ensure staff competency in GMP and quality systems.
• Coordinate monthly/quarterly metrics and regulatory reporting (FDA) for the site.
• Drive continuous improvement of quality systems and compliance with cGMP.

Skills

Quality Management

Regulatory Compliance

GMP Knowledge

Aseptic Processing

Audit Leadership

Team Leadership

Education

BS Pharmacy

Advanced degree preferred

Job description

Fagron US, a global leader in personalized pharmaceutical solutions, seeks a Quality Site Head for its Wichita, KS facility. You will oversee QA/QC, assure compliance with FDA and state regulations, lead audits, and drive continuous improvement of quality systems and processes.

The role requires robust leadership, extensive GMP knowledge, and a track record of managing quality initiatives in a sterile manufacturing environment. Competitive benefits and opportunities for advancement are offered.