Manager Quality Assurance

Commercial Distribution Quality Assurance: Create, maintain, and execute warehouse/CFA/service provider audit schedules; perform internal audits, quality visits, supplier qualifications, re-qualifications, and track CAPA closures arising from audits and regulated monitoring activities.

Cold Chain & Temperature Management: Review temperature data loggers for imported cold chain products; evaluate and approve temperature excursions during storage and distribution; maintain schedules, review, and approve temperature mapping documents for warehouses and CFAs.

Customer Complaints & Market Actions: Receive, log, acknowledge, and track customer complaints in TrackWise/SolTRAQ. Coordinate sample retrieval, interface with manufacturing sites, log CAPAs, manage service level agreements, and perform complaint trend analyses.

Regulatory Compliance & Audits: Support PV and regulatory teams during global/regulatory audits, handle FDA queries/complaints with regulatory/legal teams, manage Health Hazard Assessments, execute product/batch restrictions in SAP, and perform gap analyses on local/global SOPs.

Quality Management Systems: Deep working knowledge of TrackWise, SolTRAQ, and SAP inventory stock restriction/unrestriction processes.

Distribution & Cold Chain Compliance: Expertise in Good Distribution Practices (GDP), warehouse temperature mapping, OTMS monitoring, over-labeling controls, and cold chain excursion management.

Cross-Functional Coordination: Collaborate with regulatory, legal, manufacturing, and pharmacovigilance teams to manage market actions and maintain audit readiness.

Supplier Governance: Direct supplier qualification, performance tracking, and CAPA implementation across distribution hubs and third-party logistics providers.

Corporate Standard Shift: Standard full-time office schedule at the Mumbai BKC headquarters.

Comprehensive Compensation: Industry-aligned salary package, health insurance coverage, and professional development within Abbott's EPD Division.