Head of Quality & Compliance, Sterile Pharma (503B)

Fagron Tech; Canton, Northern (MA, KY); Hybride; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Health Insurance

Vision/Dental Insurance

Life Insurance

401K Retirement Plan

Paid Holidays

Paid Time Off & PTO rollover

Employee Assistance Program

Flexible working arrangements

Résumé du poste

Fagron US is seeking a Quality Site Head for its Canton, MA 503B outsourcing facility. You will lead QA/QC, ensure FDA/State compliance, and drive continuous improvement of quality systems to deliver compliant products.

Responsibilities include coordinating regulatory inspections, managing deviations and CAPAs, and developing staff. A strong background in sterile manufacturing, GMP, and quality leadership is essential.

Qualifications

• Bachelor of Science in Pharmacy or related field; advanced degree preferred.
• Minimum 10 years in quality/QA roles with at least 5 years in a managerial capacity.
• Experience with QC/QA in sterile pharmaceutical manufacturing.

Responsabilités

• Oversee QA and QC activities, including release, investigations, CAPAs, and changes.
• Lead regulatory inspections and customer audits; coordinate regulatory responses.
• Manage training, personnel development, and budget planning.
• Ensure compliance with cGMP, FDA/ISO standards and quality systems.

Connaissances

Leadership

Regulatory compliance

GMP knowledge

Audits

Quality systems

Formation

B.S. in Pharmacy or Science

Advanced degree preferred

Outils

QA systems (LIMS)

Description du poste

Fagron US is seeking a Quality Site Head for its Canton, MA 503B outsourcing facility. You will lead QA/QC, ensure FDA/State compliance, and drive continuous improvement of quality systems to deliver compliant products.

Responsibilities include coordinating regulatory inspections, managing deviations and CAPAs, and developing staff. A strong background in sterile manufacturing, GMP, and quality leadership is essential.