Quality Site Leader - 503B GMP & Compliance

Fagron Tech; Canton, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

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

Job summary

Fagron US seeks a Quality Site Head for our Canton, MA 503B Outsourcing facility (≈175 staff). You will drive quality systems, ensure regulatory compliance, manage QA/QC and validation activities, and lead regulatory inspections to maintain product quality and patient safety.

The role oversees investigations, deviations, change controls, training, and continuous improvement efforts in a sterile pharmaceutical environment. Strong FDA/national compliance experience is essential.

Qualifications

• Bachelor of Science or Bachelor of Pharmacy degree required; advanced degree strongly preferred.

Responsibilities

• Oversee all quality matters at the facility, including disposition of materials, release of final product, and QA/QC activities.
• Lead regulatory inspections and customer audits, providing information and follow-ups as needed.
• Manage deviations, CAPAs, change controls, and validation activities to ensure compliance.
• Develop and review monthly/quarterly quality metrics and reports; support management reviews.
• Ensure documentation and SOPs comply with regulatory requirements and company policies.

Skills

QA leadership

Quality systems

GMP knowledge

FDA audits

Aseptic processing

Education

BSc or BPharm

Job description

Fagron US seeks a Quality Site Head for our Canton, MA 503B Outsourcing facility (≈175 staff). You will drive quality systems, ensure regulatory compliance, manage QA/QC and validation activities, and lead regulatory inspections to maintain product quality and patient safety.

The role oversees investigations, deviations, change controls, training, and continuous improvement efforts in a sterile pharmaceutical environment. Strong FDA/national compliance experience is essential.