Manager – Quality Audit, Metrics and Management Review
Location: Mumbai, India – Mumbai Development Center (EPD)
Organization: Abbott
Department: Quality
Division: Established Pharmaceuticals Division (EPD)
Employment Type: Full-Time
Job ID: 31137416
Job Overview
The Manager – Quality Audit, Metrics and Management Review is responsible for managing quality data systems, audit tracking processes, and performance metrics to support divisional quality programs. The role focuses on maintaining data integrity, supporting regulatory compliance, and enabling quality management reviews through accurate reporting and analytics.
This position plays a key role in audit data management, quality metrics monitoring, stakeholder coordination, and continuous process improvement. The role requires strong technical expertise in data analytics tools, regulatory compliance knowledge, and cross-functional collaboration within a pharmaceutical quality environment.
Key Responsibilities
Quality Data Management and Analytics
Develop and maintain quality databases using Microsoft tools such as Excel, Power BI, and Forms to monitor, track, and trend quality data and documentation.
Ensure accuracy, integrity, consistency, and completeness of site and divisional quality data.
Generate reports and insights to support quality metrics and management review programs.
Audit Management and Compliance Oversight
Manage the Corporate Audit Database (ABTRAQ), including documentation of audit findings, action plans, and tracking of external agency and internal audit data.
Monitor and report audit-related activities to ensure compliance with corporate and regulatory requirements.
Deliver training and provide support on quality assurance IT systems, including ABTRAQ.
Stakeholder Engagement and Cross-Functional Collaboration
Collaborate with operational sites and business units to address inquiries and ensure completion of required documentation.
Liaise with quality and regulatory management teams to report metrics, audit findings, and product-related actions.
Interface with cross-functional teams such as commercial, distribution, and contract operations to resolve performance reporting issues.
Performance Monitoring and Issue Resolution
Identify and escalate unusual product performance or quality issues as required.
Collaborate with functional teams to investigate, discuss, and resolve quality concerns.
Maintain high standards of analytical accuracy and decision-making.
Process Improvement and Quality Excellence
Participate in process improvement initiatives, risk assessments, and strategic program development.
Support regulatory and quality system enhancements to improve operational efficiency and compliance.
Ensure adherence to applicable regulations and Good Manufacturing Practices (GMP).
Operational and Administrative Support
Provide support for management review activities, event planning, meeting coordination, and report preparation.
Track departmental projects, timelines, and communications to support quality operations.
Complete additional projects and assignments as directed by management.
Role Scope and Reporting Structure
This role reports directly to the Associate Director – Quality Metrics and Management Review.
No direct or indirect supervisory responsibilities.
Education Requirements
Bachelor’s degree in Science, Business Administration, or a technical discipline relevant to quality management and regulatory operations.
Experience Requirements
Minimum 5 years of experience in quality operations, customer support, business operations, or project planning within the pharmaceutical, healthcare, or regulated industry.
Experience working with quality audit systems, metrics reporting, or regulatory compliance processes is preferred.
Required Skills and Competencies
Advanced proficiency in Microsoft Excel and PowerPoint.
Experience with data analytics and reporting tools such as Power BI is preferred.
Knowledge of pharmaceutical regulatory standards and quality compliance requirements.
Familiarity with quality management systems such as TrackWise and other data management platforms is advantageous.
Strong analytical thinking and problem-solving skills with high attention to detail.
Excellent verbal and written English communication skills.
Ability to work independently with minimal supervision and manage multiple priorities under pressure.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Renfrew | Australia | Mississauga | Richmond Hill | North York | Uxbridge |Canada :
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Zaventem |South America :
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Tallinn |Hà Nội :
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