Pharma QA Leader - Final Product Release & Compliance

Fagron Nederland BV; Canton (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Medical, vision & dental

Health savings account

Paid time off

Job summary

Fagron US in Canton, MA, seeks a Quality Assurance leader to direct validation, training, and documentation while ensuring site compliance with cGMP and corporate standards. This role collaborates with Corporate Quality and regulatory bodies to support timely product release.

You will manage a team of pharmacists, supervise QA processes, and drive CAPA programs. Excellent regulatory knowledge and communication are essential to navigate FDA/DEA interactions and continuous improvement initiatives.

Qualifications

• Bachelor of Science with at least 5 years of QA/QA management experience.
• 3+ years of supervisory experience.
• Advanced training in cGMPs and GLPs.
• Ability to interpret federal regulations and SOPs.
• Strong data analysis and problem-solving skills.
• Excellent written and verbal communication.

Responsibilities

• Oversee QA functions for validation, training, and documentation.
• Ensure regulatory compliance and final product release.
• Lead internal and regulatory inspections with FDA/DEA interaction.
• Manage deviation investigations and CAPA closure.
• Direct QA team and coordinate with Corporate Quality.
• Maintain quality systems, change control, and documentation.

Skills

Quality Assurance Leadership

Regulatory Compliance

cGMP/GLPs

CAPA Management

Document Control

Team Supervision

Data Analysis

Education

Bachelor of Science in a related field

Advanced degree preferred

Tools

Microsoft Office (Word, Excel)

Lotus Notes

Job description

Fagron US in Canton, MA, seeks a Quality Assurance leader to direct validation, training, and documentation while ensuring site compliance with cGMP and corporate standards. This role collaborates with Corporate Quality and regulatory bodies to support timely product release.

You will manage a team of pharmacists, supervise QA processes, and drive CAPA programs. Excellent regulatory knowledge and communication are essential to navigate FDA/DEA interactions and continuous improvement initiatives.