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

• Accountable for being Management representative with Responsibility & Authority forthe Quality and Regulatory requirements; ensuring compliance to Abbott Global

Quality / Regulatory Framework, Divisional Policies / Procedures.

for suitability and adequacy for the commercial business.

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.

timely executions to minimize, any product supply interruption.

Monitoring, Maintenance & Re-Qualification).

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.

actions.

obtained, provide timely written report to appropriate management so that

necessary and appropriate measures be taken.

activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit.

mitigation, remediation and corrective activities as necessary.

activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.

and reporting activities. Assure metrics appropriately characterize the key performance indicators of the quality system.

conjunction with the Commercial office lead.

capabilities are in place to become self- sufficient in the necessary aspects of Quality.

opportunities for key talent, and drive a global mindset within the cluster.

BASIC QUALIFICATIONS | EDUCATION :

Diagnostics / Healthcare industry for a minimum of 7 years.

regulated industry.

Competencies

with external and internal customers and partners.

commercial businesses.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

Skills Required

Training, Compliance, Document Control, Quality Assurance, Risk Management