Senior Manager- Commercial Quality- & SAARC

Accountable for being Management representative with Responsibility & Authority forthe Quality and Regulatory requirements; ensuring compliance to Abbott Global
Quality/Regulatory Framework, Divisional Policies/ Procedures. Responsible for proactively creating Quality Culture w.r.t People, Process, Products & Services to meet customer needs. Maintain QMS in the market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business. Must interface and represent commercial leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues. Engage as required for the Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups through the Legal Manufacturers and Tech Support Team. Proactively reviewing product complaints and address the trends in a timely manner.

Collaborate with other global entities in fulfilling Field Corrective actions (FCA)
resulted from Regulatory Field Safety Notifications. Provide relevant quality support for post market surveillance (PMS) activities, ensure timely executions to minimize, any product supply interruption. Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies) Ensuring implementation of effective CAPA program across operational site. Driving Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification). Review/Approve Changes, Deviations, Investigations, Market Complaints & CAPA. Responsible for Budgetary Planning for Quality Operations. Evaluate the existing Quality Management System implemented in the country with the Abbott QMS and Business Unit Quality Standards and Procedures and conduct gap analysis , develop a remediation plan and drive it to achieve highest level of compliance. Responsible for the Quality Control program for imported products that are distributed in the market o Has final decision making responsibility for product release. o Has final decision making and reporting responsibilities for field corrective actions. o Collect information on product quality and when concerning information is obtained, provide timely written report to appropriate management so that necessary and appropriate measures be taken. Responsible for administration of and compliance with all major quality system activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit. Continuously drive for compliance with Abbott quality standards and regulatory requirements. Responsible for management and satisfactory resolution of product issues in a timely manner. Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary. Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings. Responsible for coordination and management of site Quality metric tracking, trending and reporting activities. Assure metrics appropriately characterize the key performance indicators of the quality system. This position will be the Commercial Quality representative for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits in conjunction with the Commercial office lead. Implement new or modify existing processes to maintain compliance with local entity, business unit, division, corporate, voluntary standards and regulatory requirements. Develop Commercial Quality team in the Cluster and the talent pool and ensure capabilities are in place to become self- sufficient in the necessary aspects of Quality. Implement Talent Strategies to grow quality capabilities, provide development opportunities for key talent, and drive a global mindset within the cluster. Other duties as assigned.