Manager – Quality Audit, Metrics & Management Review
Location: Mumbai, Maharashtra, India (Mumbai Development Center – EPD)
Category: Quality Assurance / Quality Systems
Industry: Pharmaceutical
Experience Required: Minimum 5+ years in quality systems, metrics management, audit coordination, business analytics, or project planning within the pharmaceutical industry
Job Overview
We are seeking a detail-oriented and data-driven Manager – Quality Audit, Metrics & Management Review to support divisional quality governance within a global pharmaceutical environment. This role is responsible for managing quality metrics, audit databases, management review programs, and cross-functional reporting systems to ensure regulatory compliance and data integrity.
The position plays a critical role in supporting external audits, regulatory inspections, performance tracking, and continuous improvement initiatives aligned with Good Manufacturing Practices (GMP) and global pharmaceutical standards.
Key Responsibilities
Quality Metrics & Data Governance
Create and maintain quality databases using Microsoft Excel, Power BI, and Forms to track, trend, and monitor quality data.
Ensure accuracy, integrity, completeness, and consistency of site and divisional quality metrics.
Support divisional metrics reporting and Management Review programs.
Develop dashboards and analytical tools to improve decision-making and risk visibility.
Audit Management & Compliance Oversight
Serve as Divisional Owner for the Corporate Audit Database (ABTRAQ).
Collate, document, and report audit findings, action plans, and compliance status.
Track and manage External Agency audits and Annual Quality Review (AQR) related data within ABTRAQ.
Liaise directly with AQR management for reporting audit metrics and product action data.
Deliver training and support on QA IT systems, including ABTRAQ.
Regulatory & Cross-Functional Coordination
Correspond with operations sites and business units to ensure timely completion of quality documentation.
Interface with Commercial, Distribution, Contract Operations, and other cross-functional teams to resolve performance reporting issues.
Ensure compliance with applicable pharmaceutical regulations and Good Manufacturing Practices (GMP).
Risk Management & Continuous Improvement
Participate in process improvement initiatives, strategic programs, and risk assessment teams.
Escalate unusual product performance issues with discretion and collaborate with functional teams to resolve concerns.
Contribute to regulatory readiness and quality system enhancement initiatives.
Operational & Administrative Support
Support management with event planning, meeting coordination, reporting, documentation, and project timeline tracking.
Complete additional projects assigned by senior leadership while ensuring adherence to regulatory and corporate standards.
Required Qualifications
Bachelor’s Degree in Science, Business, or a technical discipline.
Minimum 5+ years of experience in quality systems, audit coordination, metrics analytics, customer support, or project planning within the pharmaceutical industry.
Strong knowledge of pharmaceutical regulatory standards and GMP requirements.
Advanced proficiency in Microsoft Excel and PowerPoint is essential.
Experience with Power BI or similar data analytics platforms preferred.
Working knowledge of TrackWise and other quality management IT systems is desirable.
Advanced verbal and written English communication skills are mandatory.
Strong analytical thinking, accuracy, and ability to manage complex datasets.
Ability to work independently under minimal supervision and manage time-sensitive deliverables.
Reporting Structure
Reports to: Associate Director – Quality Metrics and Management Review
Direct Reports: None
Indirect Reports: None
This role is ideal for experienced pharmaceutical quality professionals with strong expertise in audit management, quality metrics analytics, regulatory compliance, and cross-functional coordination.
Apply now through ThePharmaDaily.com to advance your career in Pharmaceutical Quality Systems, Audit Governance, and Data-Driven Compliance Management.
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