Quality Site Leader - 503B Pharmacy QA/QC

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

Job summary

Fagron Sterile Services US (FSS) in Canton, MA seeks a Quality Site Head to oversee the 503B outsourcing facility's Quality Systems, ensuring FDA and state regulatory compliance. This senior role directs QA/QC, training, investigations, change controls and CAPAs to keep the site aligned with GMP standards and patient safety.

The role requires extensive GMP knowledge, leadership of regulatory activities, and the ability to drive continuous improvement across quality functions in a sterile

Qualifications

• Bachelor degree required; advanced degree strongly preferred.
• Minimum 10 years work experience with at least 5 years in managerial QC/QA in sterile pharma.
• Experience with FDA audits and GMP/ISO regulatory expectations.
• Knowledge of IV drugs, aseptic compounding, and regulatory reporting.

Responsibilities

• Oversee all Quality matters at the facility, including QA/QC, deviations, CAPAs, validation and maintenance of equipment.
• Lead regulatory inspections, customer audits, and management reviews.
• Manage budget planning and resource allocation for personnel and equipment.
• Ensure compliance with cGMP, Quality Systems, and SOPs across the site.
• Develop and mentor staff to maintain high quality standards.

Skills

Leadership

Attention to detail

Communication

Decision making

Education

Bachelor of Science or Bachelor of Pharmacy

Job description

Fagron Sterile Services US (FSS) in Canton, MA seeks a Quality Site Head to oversee the 503B outsourcing facility's Quality Systems, ensuring FDA and state regulatory compliance. This senior role directs QA/QC, training, investigations, change controls and CAPAs to keep the site aligned with GMP standards and patient safety.

The role requires extensive GMP knowledge, leadership of regulatory activities, and the ability to drive continuous improvement across quality functions in a sterile