Senior Manager – Commercial Quality (India & SAARC)
Location: Mumbai, India
Category: Quality
Industry: Medical Devices | Diagnostics | Healthcare
Job Overview
The Senior Manager – Commercial Quality will lead Quality and Regulatory functions across India and SAARC markets for Abbott ID Rapid Diagnostics. This leadership role ensures full compliance with global quality standards, regulatory frameworks, and commercial quality systems while driving continuous improvement across processes, products, and services.
This position requires an experienced quality professional capable of building a strong quality culture, managing QMS performance, and guiding cross-functional teams in a regulated environment.
Key Responsibilities
Quality Leadership & Compliance
Serve as the Management Representative with full authority for Quality and Regulatory compliance aligned with Abbott Global Quality Framework and divisional procedures.
Establish and promote a proactive quality culture across people, processes, products, and services.
Maintain and monitor the Quality Management System (QMS) to ensure suitability, adequacy, and continuous improvement.
Quality Operations & Decision-Making
Act as the primary quality representative supporting commercial leaders in escalations, field actions, and significant quality issues.
Oversee product quality complaints, ensuring timely investigation, resolution, closure, and communication in partnership with Legal Manufacturers and Technical Support teams.
Collaborate with global teams on Field Corrective Actions (FCA) arising from regulatory notifications.
Regulatory & Compliance Activities
Support Post-Market Surveillance (PMS) activities to ensure uninterrupted product supply.
Facilitate external and internal audits, including Corporate Quality Audits, Regulatory Audits, and ISO audits.
Implement an effective CAPA program across operational sites.
Lead Supplier Qualification, including identification, audits, monitoring, and re-qualification.
Quality Control & Product Release
Oversee Quality Control for imported products distributed in the market.
Hold final decision-making authority for product release and field corrective actions.
Report product quality concerns promptly to leadership for timely action.
Quality System Administration
Manage document control, record control, training, CAPA, quality incidents, risk management, and internal audits.
Ensure adherence to Abbott quality standards and regulatory requirements.
Drive timely containment, remediation, and corrective actions for product-related issues.
Performance Monitoring & Reviews
Lead Quality Management Review activities, including quarterly reporting and issue escalation.
Manage Quality metrics, ensuring accurate tracking, trending, and reporting of KPIs.
Represent Commercial Quality during internal compliance reviews and third-party inspections.
Team Leadership & Talent Development
Develop and strengthen the Commercial Quality team across the cluster to achieve self-sufficiency.
Implement talent development strategies, build capabilities, and promote a global mindset.
Continuously refine processes to meet local, regional, and corporate quality requirements.
Required Qualifications & Experience
Bachelor’s degree in Pharmacy, Science, or Engineering.
Minimum 10 years of experience in Quality Assurance and/or Compliance within a regulated Medical Device, Pharmaceutical, In-Vitro Diagnostics, or Healthcare environment.
Minimum 7 years of industry experience in Medical Devices/Diagnostics/Pharma.
At least 3 years of supervisory or managerial experience in quality functions.
Strong command of English communication (verbal and written).
Core Competencies
Proven leadership and influence across cross-functional teams.
Strong analytical, decision-making, and communication skills.
Ability to manage multiple priorities across diverse business units.
Expertise in medical device quality regulations and compliance requirements.
Experience handling audits, inspections, CAPA, supplier qualification, and PMS activities.
Ability to work in a fast-paced, matrixed, and multicultural environment.
High attention to detail and accuracy.
Equal Opportunity Statement
Abbott is an equal opportunity employer committed to diversity and inclusion. We provide reasonable accommodations for qualified individuals with disabilities.
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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