Senior QA Supervisor: cGMP Compliance & Team Leadership

Fagron Nederland BV; Canton, Northern (MA, KY); Hybrid; USD 95,000 - 135,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision & dental insurance

Health Savings Account (HSA)

Job summary

Fagron US seeks a Quality Assurance Supervisor to lead QA activities for cGMP manufacturing, documentation, and product disposition. You will manage a team, ensure ALCOA-compliant records, and support audits and change controls.

The role emphasizes leadership, quality systems, and rapid decision-making to maintain compliance across manufacturing, packaging, and warehousing of compounded products.

Qualifications

• College degree required and >10 years of cGMP experience in pharma manufacturing or equivalent.
• Experience with quality systems, aseptic technique, cGMP document review, investigations, CAPA, Change Control, MasterControl preferred.
• Proficient in MS Office (Word, Excel).
• Ability to process information rapidly from multiple sources and communicate effectively.
• Ability to manage high workload and adapt to changing environment.

Responsibilities

• Coach and lead direct reports in Level 1–3 QA tasks and ensure proficiency.
• Lead QA documentation controls, batch records, and review/approval processes.
• Oversee change controls, event reports, and corrective actions.
• Support audits and inspections (internal, corporate, 3rd party, and regulatory).
• Ensure cGMP documentation meets ALCOA standards.

Skills

Leadership

Quality Assurance

Document Review

CAPA

Communication

Education

College Degree

Tools

MasterControl

MS Office

Job description

Fagron US seeks a Quality Assurance Supervisor to lead QA activities for cGMP manufacturing, documentation, and product disposition. You will manage a team, ensure ALCOA-compliant records, and support audits and change controls.

The role emphasizes leadership, quality systems, and rapid decision-making to maintain compliance across manufacturing, packaging, and warehousing of compounded products.