QA Compliance Manager

Local applicants only – not for global assignments or employees working outside of Cipla's U.S. subsidiaries or affiliates.

About the role

The QA Compliance Manager is responsible for ensuring that all compliance-related activities comply with U.S. regulatory requirements, primarily governed by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 210, 211, and 820, as well as other applicable regulations. The role focuses on maintaining inspection readiness and ensuring adherence to Current Good Manufacturing Practice (cGMP) requirements for pharmaceutical manufacturing.

Responsibilities

• Ensure timely and effective closure of all internal, external, regulatory, and customer audit observations through robust corrective and preventive actions (CAPA).
• Independently prepare, review, and submit Field Alert Reports (FARs) in accordance with FDA regulatory requirements.
• Lead and manage initiation and execution of product recalls at various levels, ensuring regulatory compliance and effective cross-functional coordination.
• Oversee document control operations, ensuring accurate receipt, review, archival, and maintenance of controlled documents in compliance with data integrity and record-keeping requirements.
• Ensure timely submission of documents to Iron Mountain.
• Ensure the document control room is managed properly and ready for audits at all times.
• Maintain continuous inspection readiness for internal, external, and regulatory audits through proactive quality oversight and compliance monitoring.
• Develop, manage, and execute the site internal audit program, including audit scheduling, conduct, reporting, and follow-up activities.
• Identify, investigate, and remediate site-wide data integrity issues to ensure compliance with regulatory expectations and industry best practices.
• Ensure compliance with applicable FDA regulations, including 21 CFR Parts 210 and 211, 21 CFR Part 11 (Electronic Records and Signatures), and 21 CFR Part 820, as applicable.
• Interpret and implement FDA guidance documents, compliance policies, and regulatory expectations across site quality systems.
• Monitor FDA regulatory updates and industry trends to assess impact and ensure ongoing site compliance and operational readiness.
• Serve as the primary Quality Assurance representative and lead during FDA inspections, including Pre-Approval Inspections (PAI), routine surveillance, and for-cause inspections.
• Lead the preparation and submission of responses to FDA Form 483 observations.
• Track and manage site-wide training activities to ensure timely completion and maintain zero overdue or pending training requirements, supporting continuous inspection readiness.
• Collaborate closely with Regulatory Affairs and cross-functional stakeholders to align inspection strategies, communication plans, and regulatory responses.
• Review FDA Form 483 observations and ensure implementation of agreed corrective actions across the facility.
• Coordinate cross-functional meetings to drive compliance activities, define action plans, assign responsibilities, and ensure timely completion of commitments and target completion dates (TCDs).
• Review deviations, CAPA, and change requests initiated against audit observations to ensure requirements are met.
• Impart data integrity and GDP-related training to new hires during orientation programs.
• Investigate and review market/product complaints for commercialized products and ensure timely closure as per SOP timelines.
• Send complaint-related samples to outside vendors for investigation.
• Perform any other work assigned by the Head of Unit Quality Assurance and Site Quality Head.

Requirements

• Minimum of a bachelor’s degree in Chemistry, Pharmaceutical Sciences, Quality Management, or a related field from an accredited institution.
• Minimum of ten (10) years of collective work experience in a QA Department or QC lab, preferably in a pharmaceutical manufacturing company.
• Minimum of two (2) years of supervisory and team leadership experience, including both hourly and salaried staff.
• Working knowledge and direct application of cGMP and regulatory guidelines related to QA, pharmaceutical manufacturing, computerized system validation, equipment validation, and data integrity.
• Relevant understanding and knowledge of 21 CFR Part 11 regulations.
• Prior experience with MDIs or drug-device combination products is preferred.

About the company

Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines. With a presence in key markets such as India, South Africa, and the U.S., Cipla is trusted by healthcare professionals and patients worldwide. The company employs professionals driven by a vision to make affordable, world-class medicines accessible to all, with a reputation for uncompromising quality standards.

InvaGen Pharmaceuticals, Inc., a Cipla subsidiary, focuses on the development, manufacture, marketing, and distribution of generic prescription medicines across therapeutic areas including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants.

Pay

$86,000 - $113,500 per year.

Schedule

General: 8:30 AM – 5:00 PM (may vary based on business needs).