Senior Manager- Commercial Quality- India & SAARC

PURPOSE
This position will provide Commercial Quality Leadership to India and SAARC markets in Abbott ID Rapid Diagnostics business.

RESPONSIBILITIES:
u2022 Accountable for being Management representative with Responsibility & Authority forthe Quality and Regulatory requirements ensuring compliance to Abbott GlobalQuality/Regulatory Framework, Divisional Policies/ Procedures.u2022 Responsible for proactively creating Quality Culture w.r.t People, Process, Products & Services to meet customer needs.u2022 Maintain QMS in the market and continually evaluate and monitor the quality systemfor suitability and adequacy for the commercial business.u2022 Must interface and represent commercial leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.u2022 Engage as required for the Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups through the LegalManufacturers 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.u2022 Provide relevant quality support for post market surveillance (PMS) activities, ensuretimely executions to minimize, any product supply interruption.u2022 Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)u2022 Ensuring implementation of effective CAPA program across operational site.u2022 Driving Supplier Qualification Program (Identification, Evaluation through Audits,Monitoring, Maintenance & Re-Qualification).u2022 Review/Approve Changes, Deviations, Investigations, Market Complaints & CAPA.u2022 Responsible for Budgetary Planning for Quality Operations.u2022 Evaluate the existing Quality Management System implemented in the country with theAbbott QMS and Business Unit Quality Standards and Procedures and conduct gapanalysis , develop a remediation plan and drive it to achieve highest level ofcompliance.u2022 Responsible for the Quality Control program for imported products that are distributed in the marketo Has final decision making responsibility for product release.o Has final decision making and reporting responsibilities for field correctiveactions.o Collect information on product quality and when concerning information isobtained, provide timely written report to appropriate management so thatnecessary and appropriate measures be taken.u2022 Responsible for administration of and compliance with all major quality systemactivities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit.u2022 Continuously drive for compliance with Abbott quality standards and regulatory requirements.u2022 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.u2022 Coordinate with entity management and facilitate Quality Management Reviewactivities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.u2022 Responsible for coordination and management of site Quality metric tracking, trendingand reporting activities. Assure metrics appropriately characterize the key performance indicators of the quality system.u2022 This position will be the Commercial Quality representative for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits inconjunction with the Commercial office lead.u2022 Implement new or modify existing processes to maintain compliance with local entity, business unit, division, corporate, voluntary standards and regulatory requirements.u2022 Develop Commercial Quality team in the Cluster and the talent pool and ensurecapabilities are in place to become self- sufficient in the necessary aspects of Quality.u2022 Implement Talent Strategies to grow quality capabilities, provide developmentopportunities for key talent, and drive a global mindset within the cluster.u2022 Other duties as assigned.

BASIC QUALIFICATIONS | EDUCATION:
u2022 Bachelor Degree in Pharmacy/Science/Engineering.u2022 Must have been employed in the Medical Device/Pharmaceutical /In-VitroDiagnostics/Healthcare industry for a minimum of 7 years.u2022 Minimum of 10 years of experience in Quality Assurance and /or Compliance in aregulated industry.u2022 Minimum of 3 years supervisory / managerial experienceu2022 Ability to effectively communicate in English.

COMPETENCIES:
u2022 Strong leadership influence.u2022 Strong analytical, communication, decision-making and leadership skills for interactionwith external and internal customers and partners.u2022 Strong ability to negotiate with stakeholders.u2022 Able to manage multiple priorities and pull information together from multiple business units to ensure concise consolidated business picture is communicated to thecommercial businesses.u2022 Superior attention to accuracy and details.u2022 Strong leadership skills, including the ability to set goals and provide constructive feedback respectfully in order to build positive relationships and improve business results.u2022 Capable of understanding and overcoming different cultural and language barriers to provide solutions that satisfy corporate, regional, and local objectives.u2022 Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.u2022 Strong knowledge of relevant medical device industry regulations for quality systems and compliance.u2022 Ability to work in a highly matrixed and geographically diverse business environment.u2022 Ability to work effectively within a team in a fast-paced changing environment. Multitasks, prioritizes and meets deadlines in timely manner.u2022 Experience in conducting and handling audits and inspections.An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.