QA Compliance Lead – FDA & cGMP Inspections

Creative Solutions Services, LLC; Fall River (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Assurance Compliance Manager in Fall River, MA to oversee FDA‑regulated QA activities and maintain cGMP compliance. You will lead CAPA processes, manage audits, and coordinate regulatory responses, ensuring inspection readiness across the site.

The role reports to the Head of Quality Assurance and requires extensive experience with FDA regulations, CFR Part 11, and data integrity.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, quality management or related field.
• 10+ years in QA, preferably in pharmaceutical manufacturing.
• 2 years supervisory experience.
• Working knowledge of cGMP and regulatory guidelines.
• Knowledge of CFR Part 11 and electronic records.
• Experience with FDA inspections and CAPA processes.

Responsibilities

• Ensure timely and effective closeout of audit observations via CAPA.
• Prepare, review, and submit Field Alert Reports (FARs) per FDA requirements.
• Lead recalls and coordinate cross‑functional actions to ensure regulatory compliance.
• Oversee document control, data integrity, and record-keeping compliance.
• Maintain site inspection readiness and coordinate internal audit program.
• Lead responses to FDA Form 483 observations and QA during inspections.

Skills

CAPA management

Audit coordination

Regulatory compliance

Data integrity

Education

Bachelor's degree in chemistry or pharmaceutical sciences or related field

Job description

Creative Solutions Services, LLC is seeking a Quality Assurance Compliance Manager in Fall River, MA to oversee FDA‑regulated QA activities and maintain cGMP compliance. You will lead CAPA processes, manage audits, and coordinate regulatory responses, ensuring inspection readiness across the site.

The role reports to the Head of Quality Assurance and requires extensive experience with FDA regulations, CFR Part 11, and data integrity.