Senior Manager – Commercial Quality (India & SAARC)
Location: Mumbai, India
Category: Quality
Platform: ThePharmaDaily.com Global Job Portal
The Senior Manager – Commercial Quality will provide leadership and oversight for Quality operations across the India and SAARC markets for the Rapid Diagnostics business. This role ensures compliance with global and regional quality and regulatory frameworks while driving a strong quality culture within commercial teams.
Quality Leadership and Compliance
Serve as the Management Representative with full authority for Quality and Regulatory compliance in alignment with Abbott Global Quality and Regulatory Frameworks.
Build and promote a proactive Quality Culture across people, processes, products and services.
Maintain and continuously improve the Quality Management System (QMS), ensuring its suitability and effectiveness for commercial operations.
Represent commercial leadership in escalations, field actions and critical quality decisions.
Quality Operations Management
Lead and support the investigation, resolution and closure of product quality complaints, ensuring timely follow-up and trend analysis.
Collaborate with global teams to implement Field Corrective Actions resulting from Regulatory Field Safety Notifications.
Provide quality oversight for Post Market Surveillance (PMS) to avoid supply interruptions.
Facilitate internal and external audits, including corporate quality audits, regulatory inspections and ISO audits.
Oversee CAPA programs, driving identification, root-cause analysis and effective implementation.
Lead Supplier Qualification activities including identification, audit evaluation, monitoring, maintenance and requalification.
Review and approve changes, deviations, investigations, market complaints and CAPA reports.
Manage budget planning for Quality Operations.
Quality Systems and Controls
Evaluate local QMS against corporate and business unit standards, conduct gap analyses and implement remediation plans.
Oversee Quality Control processes for imported products, including final product release and decision-making for field corrective actions.
Ensure compliance with document control, record control, training, quality incidents, risk management and internal audit requirements.
Coordinate containment, mitigation, remediation and corrective actions for product issues across functional teams.
Lead Quality Management Review activities and ensure closure of action items.
Manage Quality metrics, including tracking, trending and reporting key performance indicators.
Act as the primary Quality representative for internal compliance reviews and third-party audits.
Organizational Development
Strengthen Commercial Quality capabilities within the cluster, developing a self-sufficient team with strong technical and leadership competencies.
Implement talent development strategies to support global quality standards and foster a unified, regionally aligned mindset.
Adapt and implement new or updated processes to maintain regulatory and corporate compliance.
Education
Bachelor’s degree in Pharmacy, Science or Engineering.
Experience
Minimum 10 years of experience in Quality Assurance or Compliance within a regulated industry (Medical Devices, Pharmaceuticals, In-Vitro Diagnostics or Healthcare).
Minimum 7 years of industry experience in medical devices, pharma or diagnostics.
Minimum 3 years of supervisory or managerial experience.
Proven experience in handling audits and regulatory inspections.
Strong English communication skills.
Strong leadership, analytical and decision-making capabilities.
Ability to negotiate effectively with internal and external stakeholders.
Skilled in managing multiple priorities across cross-functional and multi-regional teams.
High attention to accuracy, detail and compliance.
Ability to work in a matrixed, fast-paced and geographically diverse environment.
Strong understanding of medical device quality regulations and standards.
Demonstrated ability to overcome cultural and language barriers in multinational settings.
This job listing has been fully enhanced for SEO, GEO targeting and GPT optimization to ensure maximum visibility on ThePharmaDaily.com, attracting qualified global talent across the pharmaceutical, medical device and diagnostics sectors.
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