QA Compliance Lead – FDA Audits & Inspection Readiness

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

Job summary

Cipla in Fall River, MA seeks a Quality Assurance Compliance Manager to oversee FDA compliance, cGMP adherence, and audit readiness. You will lead CAPA closures, FAR preparation, and recalls, ensuring controlled document management and data integrity.

This role requires coordinating with Regulatory Affairs and cross-functional teams for timely regulatory responses at site level. You will supervise QA activities, drive internal audits, and maintain readiness for FDA inspections, including PAIs

Qualifications

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, QualityManagement or related field.
• Minimum of ten years of collective QA experience, preferably in pharma manufacturing.
• Minimum of two years supervisory and team leadership experience.

Responsibilities

• Close audit observations via robust CAPA actions and timely responses.
• Prepare and submit FARs in compliance with FDA requirements.
• Lead recalls and ensure cross‑functional regulatory coordination.
• Oversee document control with data integrity and record-keeping.
• Maintain inspection readiness and lead FDA inspection activities.
• Develop, manage, and execute the site internal audit program.
• Investigate data integrity issues and ensure regulatory compliance.
• Review and implement CFR Part 11, 21 CFR Parts 210, 211, and 820 guidance.
• Coordinate training and align regulatory responses with stakeholders.

Skills

CAPA management

Audit readiness

FDA inspections

Document control

Data integrity

cGMP compliance

Regulatory compliance

FARs submission

Education

Bachelor’s degree in chemistry

Bachelor’s degree in Pharmaceutical Sciences

Bachelor’s degree in QualityManagement

Job description

Cipla in Fall River, MA seeks a Quality Assurance Compliance Manager to oversee FDA compliance, cGMP adherence, and audit readiness. You will lead CAPA closures, FAR preparation, and recalls, ensuring controlled document management and data integrity.

This role requires coordinating with Regulatory Affairs and cross-functional teams for timely regulatory responses at site level. You will supervise QA activities, drive internal audits, and maintain readiness for FDA inspections, including PAIs