QA Compliance Lead – FDA & Inspections

Cipla USA Inc.; Fall River (MA); On-site; USD 86,000 - 114,000; Full time

Job summary

Cipla USA Inc. in Fall River, MA is seeking a Quality Assurance Compliance Manager to oversee FDA compliance and cGMP for pharmaceutical manufacturing. You will manage audits, CAPA, training, and document control to ensure inspection readiness and regulatory alignment.

The role reports to the Head of Quality Assurance and requires extensive QA leadership, cross-functional collaboration, and a commitment to data integrity and regulatory excellence.

Qualifications

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, QualityManagement or related field.
• Ten years of collective work experience in QA within pharmaceutical manufacturing.
• Minimum of two years supervisory and team leadership experience.
• Working knowledge of cGMP and CFR parts 11/210/211/820.

Responsibilities

• Ensure timely closure of audit observations through CAPA.
• Prepare, review, and submit FARs according to FDA requirements.
• Lead product recalls with cross-functional coordination.
• Oversee document control, data integrity, and record-keeping compliance.
• Maintain site inspection readiness and training compliance.
• Develop, manage, and execute the internal audit program.
• Monitor regulatory updates and ensure ongoing site compliance.
• Respond to FDA 483 observations and regulatory inquiries.

Skills

Regulatory compliance

Quality assurance

FDA inspections

CAPA management

Training & supervision

Data integrity

Document control

Education

Bachelor’s degree in chemistry, Pharmaceutical Sciences, QualityManagement or related field

Job description

Cipla USA Inc. in Fall River, MA is seeking a Quality Assurance Compliance Manager to oversee FDA compliance and cGMP for pharmaceutical manufacturing. You will manage audits, CAPA, training, and document control to ensure inspection readiness and regulatory alignment.

The role reports to the Head of Quality Assurance and requires extensive QA leadership, cross-functional collaboration, and a commitment to data integrity and regulatory excellence.