QA Compliance Leader: FDA‑Ready & Audit Mastery

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

Job summary

Cipla in Fall River, MA seeks a Quality Assurance Compliance Manager to lead FDA-compliance efforts, maintain cGMP standards, and ensure inspection readiness. You will drive CAPA, manage audits, and coordinate recalls. This role reports to the Head of Quality Assurance and requires deep regulatory knowledge.

The position emphasizes cross-functional leadership, rigorous document control, and proactive quality oversight to sustain regulatory compliance and product integrity across the site.

Qualifications

• Bachelor's degree in chemistry, Pharmaceutical Sciences, QualityManagement or related field from an accredited institution.

Responsibilities

• Ensure timely and effective closure of audit observations through CAPA.
• Prepare, review, and submit FARs per FDA regulatory requirements.
• Lead and manage initiation and execution of product recalls with regulatory compliance and cross-functional coordination.
• Oversee document control operations ensuring accurate receipt, review, archival, and maintenance of controlled documents in compliance with data integrity.
• Ensure timely submission of documents to relevant systems.
• Maintain site inspection readiness for internal, external, and regulatory audits.
• Develop, manage, and execute the site internal audit program including scheduling, conduct, reporting, and follow-up.
• Identify, investigate, and remediate site-wide data integrity issues.
• Monitor FDA regulatory updates and industry trends to assess impact on site compliance.
• Serve as the QA representative during FDA inspections and for-cause inspections.
• Lead preparation and submission of responses to FDA Form 483 observations.
• Track and manage site-wide training to ensure timely completion and zero overdue training.
• Collaborate with Regulatory Affairs to align inspection strategies and regulatory responses.
• Review FDA Form 483 observations and ensure CAPA actions are implemented.
• Coordinate cross-functional meetings to drive compliance activities with clear action plans.
• Review deviations, CAPA and change controls related to audits to ensure requirements are met.
• Impart data integrity and GDP training to new hires during orientation.
• Investigate and review market/product compliance for commercialized products.

Skills

CAPA management

FDA/Regulatory compliance

Audit readiness

Quality systems oversight

Cross-functional collaboration

Team leadership

Document control

Regulatory inspections

Education

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

Job description

Cipla in Fall River, MA seeks a Quality Assurance Compliance Manager to lead FDA-compliance efforts, maintain cGMP standards, and ensure inspection readiness. You will drive CAPA, manage audits, and coordinate recalls. This role reports to the Head of Quality Assurance and requires deep regulatory knowledge.

The position emphasizes cross-functional leadership, rigorous document control, and proactive quality oversight to sustain regulatory compliance and product integrity across the site.