FDA QA Compliance Leader (cGMP & Inspections)

Aequor; Fall River (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Aequor in Fall River, MA seeks a QA Compliance Manager to ensure FDA regulatory compliance and maintain inspection readiness. You will lead audit responses, CAPA programs, and recalls, while coordinating with Regulatory Affairs and cross-functional teams to uphold cGMP and data integrity throughout the site.

The role requires extensive QA experience, strong leadership, and the ability to manage document control and training activities to sustain zero overdue items and timely audits.

Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Quality Management or related field from an accredited institution.
• Total of 10+ years in QA, QC, or related roles in pharmaceutical manufacturing.
• Minimum 2 years supervisory experience with both hourly and salaried staff.
• Working knowledge of cGMP and CFR part 11 regulations, data integrity and validation.

Responsibilities

• Ensure timely closure of internal, external, regulatory, and customer audit observations via CAPA.
• Prepare and submit FARs per FDA requirements.
• Lead and manage product recalls with cross-functional coordination.
• Oversee document control to ensure data integrity and proper archival.

Skills

cGMP knowledge

Regulatory guidelines

Data integrity

FDA CFR Part 11

Audit readiness

Education

Bachelor's degree in Chemistry

Pharmaceutical Sciences

Quality Management or related field

Job description

Aequor in Fall River, MA seeks a QA Compliance Manager to ensure FDA regulatory compliance and maintain inspection readiness. You will lead audit responses, CAPA programs, and recalls, while coordinating with Regulatory Affairs and cross-functional teams to uphold cGMP and data integrity throughout the site.

The role requires extensive QA experience, strong leadership, and the ability to manage document control and training activities to sustain zero overdue items and timely audits.