Head of Quality & GMP Operations (Sterile Pharma)

Fagron; Canton (MA); On-site; 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

Paid Time Off and Rollover

401K/Retirement Savings Plans

Employee Assistance Program

Flexible working arrangements

Job summary

Fagron US is seeking a Quality Site Head for its 503B Outsourcing facility in Canton, MA, overseeing QA/QC, environmental monitoring, and change controls to ensure FDA and state regulatory compliance.

The role leads QA/QC investigations, audits, and management reviews, while coordinating training, budgets, and staff development for a ~175-person site. Strong GMP knowledge and leadership are essential.

Qualifications

• Bachelor of Science or Bachelor of Pharmacy degree required; advanced degree strongly preferred.
• Minimum 10 years work-related experience including at least 5 years as a manager of QC and QA functions in a sterile pharmaceutical manufacturing facility.
• Extensive understanding of FDA GMP and ISO 14644; experience with FDA audits and compliance.
• Training in quality systems and an understanding of compounding center design and operations.

Responsibilities

• Oversee QA/QC at the facility, including disposition of materials and final product, and management of CAPAs and deviations.
• Lead regulatory inspections and customer audits; manage documentation and cross-functional reporting.
• Participate in budget planning and resource allocation; develop and mentor direct reports.
• Ensure compliance with cGMP and corporate Quality System requirements across the site.

Skills

Leadership

Collaboration

Attention to detail

Education

Bachelor of Science

Bachelor of Pharmacy

Job description

Fagron US is seeking a Quality Site Head for its 503B Outsourcing facility in Canton, MA, overseeing QA/QC, environmental monitoring, and change controls to ensure FDA and state regulatory compliance.

The role leads QA/QC investigations, audits, and management reviews, while coordinating training, budgets, and staff development for a ~175-person site. Strong GMP knowledge and leadership are essential.