Abbott - Senior Manager - Commercial Quality

position will provide Commercial Quality Leadership to India and SAARC markets in Abbott ID Rapid Diagnostics 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
• Has final decision making responsibility for product release.
• Has final decision making and reporting responsibilities for field corrective actions.
• 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.

BASIC QUALIFICATIONS | EDUCATION :

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities

(ref : iimjobs.com)