QA Compliance Manager

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Ciplas U.S. Subsidiaries or Affiliates.

Job Title: Quality Assurance Compliance Manager

Work Location: Fall River MA

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

Reports To: Head of Quality Assurance

Salary Range: $86000 - $113500

Purpose

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 210211 and 820 and other applicable regulations. The role focuses on maintaining inspection readiness and ensuring adherence to Current Good Manufacturing Practice (cGMP) requirements for pharmaceutical manufacturing.

Job 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 crossfunctional coordination.
• Oversee document control operations ensuring accurate receipt review archival and maintenance of controlled documents in compliance with data integrity and recordkeeping requirements.
• Ensure timely submission of document to iron mount.
• Ensure document control room is managed properly and ready for all time audit.
• 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 followup activities.
• Identify investigate and remediate sitewide 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 PreApproval Inspections (PAI) routine surveillance and forcause 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 crossfunctional 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 crossfunctional meetings to drive compliance activities define action plans assign responsibilities and ensure timely completion of commitments and target completion dates (TCDs).
• Review the deviation CAPA and change request initiated against the audit observation to ensure the observation requirements are met.
• Impart data integrity and GDP related training to new hire during orientation program.
• Investigate and review the market/ product compliant for commercialized product and ensure its onetime closure as per SOP timeline.
• Send the compliant related sample to outside vendor for investigation.
• Any other work assigned by Head Unit Quality Assurance and Site Quality Head.

Educational & Experience:

• Minimum of a bachelors degree in chemistry Pharmaceutical Sciences QualityManagement or related field of study from an accredited institution.

• Minimum of ten (10) years of collective work experience in QA Department QClab preferably in a pharmaceutical manufacturing company preferred.

• Minimum of two (2) years supervisory and team leadership experience both hourlyand salaried staff.

• Working knowledge and direct application of cGMP and regulatory guidelinesrelated to QA pharmaceutical manufacturing and computerized systemvalidation equipment validation and data integrity.
• Relevant understanding and knowledge about CFR part 11 regulations.
• Preferably have prior MDI experience or in Drug Device combination products.

GLOBAL COMPANY

Cipla is a leading global pharmaceutical company dedicated to high-quality branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades we have strengthened our leadership in Indias pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India South Africa the U.S. and other economies of the emerging employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision none shall be denied Ciplas focus has always been on making affordable world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS INC.)

About InvaGen Pharmaceuticals a Cipla subsidiary: InvaGen Pharmaceuticals Inc. is engaged in the development manufacture marketing and distribution of generic prescription medicines with focus on a range of therapeutic areas including cardiovascular anti-infective CNS anti-inflammatory anti-diabetic and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge New York. As of February 18 2016 InvaGen Pharmaceuticals Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement:

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color age sex sexual orientation gender identity religion national origin genetic information disability or protected veteran status.