Manager – Quality Audit, Metrics & Management Review
Experience: 5+ Years | Location: Mumbai, India – Mumbai Development Center (EPD) | Category: Quality | Employment Type: Full-Time
Company Overview:
Join a leading pharmaceutical organization dedicated to ensuring quality, compliance, and continuous improvement across its operations. The Manager – Quality Audit, Metrics & Management Review will play a pivotal role in maintaining high standards of data integrity, reporting, and analytics to support divisional quality programs and management review processes.
Role Overview:
The Manager is responsible for creating, maintaining, and analyzing quality data to support audit, metrics, and management review initiatives. This role requires advanced technical competence, strong analytical abilities, and collaboration across multiple functional areas to ensure compliance with regulatory standards and Good Manufacturing Practices (GMP).
Key Responsibilities:
Develop and maintain quality tracking databases using Microsoft systems (Excel, PowerBI, Forms) to monitor and trend divisional metrics and management review data.
Ensure integrity, accuracy, consistency, and completeness of site and division quality data.
Act as division owner for the Corporate Audit Database (ABTRAQ), including collating, documenting, reporting findings, and tracking actions for external agency and AQR audits.
Deliver training and provide support for QA IT systems, including ABTRAQ.
Liaise with AQR management to report metrics, audit outcomes, and product action data.
Collaborate with multi-functional areas (Commercial, Distribution, Contract Operations, etc.) to document, review, and resolve performance reporting issues.
Participate in process improvement initiatives, risk assessments, and strategic program development for regulatory and quality activities.
Support management in event planning, meeting preparation, report generation, and departmental project tracking.
Exercise discretion in escalating unusual product performance issues and collaborate with functional areas to resolve them.
Complete other projects as assigned while ensuring compliance with applicable regulations and GMP standards.
Required Skills and Competencies:
Advanced knowledge of Microsoft Excel and PowerPoint; experience with PowerBI or similar data analytics tools preferred.
Strong technical competence, analytical thinking, and problem-solving skills.
Excellent verbal and written English communication skills.
Ability to work independently with minimal supervision and manage work under pressure.
Knowledge of applicable pharmaceutical regulatory standards and requirements.
Familiarity with systems such as Trackwise and general IT system data entry/report generation is desirable.
High degree of accuracy and attention to detail in data analysis and reporting.
Educational Qualification:
Bachelor’s degree in Science, Business, or a related technical field.
Experience Requirements:
Minimum 5 years of relevant experience in quality audit, metrics, project planning, or business support roles within a pharmaceutical or regulated environment.
Reporting Line:
Reports directly to the Associate Director – Quality Metrics and Management Review.
Supervisory Responsibilities:
Individual contributor; no direct or indirect reports.
Why Join Us:
Work in a dynamic, quality-driven environment with cross-functional exposure.
Lead initiatives in audit, metrics, and management review to enhance compliance and operational excellence.
Contribute to continuous improvement programs and data-driven decision-making within a global pharmaceutical organization.
Apply Now: Advance your career as a Manager – Quality Audit, Metrics & Management Review in Mumbai and play a key role in ensuring the integrity, accuracy, and effectiveness of quality and compliance operations.
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