Quality Site Leader - GMP, FDA & Compliance

Fagron Nederland BV; Canton (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Life insurance

Paid holidays

Paid time off

401K with company match

Employee assistance program

Flexible working arrangements

Job summary

Fagron US in Canton, MA, seeks a Quality Site Head to own the quality systems and regulatory compliance for a 175-person facility. You will oversee QA/QC, investigations, CAPAs, and change controls to ensure final product safety and efficacy for FDA and state boards.

You will lead audits, trainings, and regulatory interactions, while guiding budgeting and team development to maintain top-tier GMP standards and ongoing improvements.

Qualifications

• Bachelor's degree in science or pharmacy, with strong GMP knowledge.
• 10+ years in QA/QC roles within sterile pharma settings.
• Experience leading audits by FDA or equivalent bodies.
• Proven ability to design, implement and sustain QMS.

Responsibilities

• Oversee QA and QC at the Canton facility, including release, investigations, CAPA and deviations.
• Lead regulatory inspections and customer audits, and coordinate responses.
• Direct training, equipment validation, environmental monitoring, and calibration programs.
• Manage budgets, resources, and direct reports with strategic planning.
• Ensure compliance with cGMP, ISO 14644 and related regulatory requirements.
• Develop metrics, prepare reports, and drive continuous improvement initiatives.

Skills

Leadership

Regulatory knowledge

Quality systems

People management

Education

Bachelor of Science or Bachelor of Pharmacy

Advanced degree preferred

Job description

Fagron US in Canton, MA, seeks a Quality Site Head to own the quality systems and regulatory compliance for a 175-person facility. You will oversee QA/QC, investigations, CAPAs, and change controls to ensure final product safety and efficacy for FDA and state boards.

You will lead audits, trainings, and regulatory interactions, while guiding budgeting and team development to maintain top-tier GMP standards and ongoing improvements.