Senior Manager- Commercial Quality- India & SAARC at Abbott

Mumbai, Maharashtra, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical DevicesIndustries

Requirements

Experience in providing Commercial Quality Leadership in markets like India and SAARC
Knowledge of Abbott Global Quality/Regulatory Framework, Divisional Policies/Procedures
Ability to act as Management representative with Responsibility & Authority for Quality and Regulatory requirements
Skills in interfacing with commercial leaders on quality decisions (escalations, field actions, significant quality issues)
Expertise in engaging with Quality Complaints, investigations, resolutions, and customer follow-ups
Capability to collaborate globally on Field Corrective Actions (FCA) from Regulatory Field Safety Notifications
Proficiency in post-market surveillance (PMS) activities
Experience facilitating Audits (Corporate Quality, Regulatory, ISO-Notified Bodies)
Knowledge of implementing effective CAPA programs
Expertise in driving Supplier Qualification Programs (Identification, Evaluation, Audits, Monitoring, Maintenance, Re-Qualification)
Ability to review/approve Changes, Deviations, Investigations, Market Complaints & CAPA
Skills in Budgetary Planning for Quality Operations
Experience conducting gap analysis on Quality Management Systems (QMS) against Abbott standards and driving remediation plans
Responsibility for Quality Control program for imported products, including final decision-making for product release and field corrective actions
Knowledge of administering quality system activities (document control, record control, training, CAPA, quality incidents, risk management, internal audit)
Ability to coordinate cross-functionally for containment, mitigation, remediation, and corrective activities
Skills in facilitating Quality Management Review activities, including quarterly reporting and escalation
Experience in Quality metric tracking, trending, and reporting
Capability to represent as Commercial Quality lead for internal compliance and 3rd party audits/inspections
Ability to implement or modify processes for compliance with local, business unit, division, corporate, voluntary standards, and regulatory requirements
Skills in developing Commercial Quality teams and talent pools

Responsibilities

Accountable for being Management representative with Responsibility & Authority for the Quality and Regulatory requirements; ensuring compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/Procedures
Proactively create 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
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 Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups through Legal Manufacturers and Tech Support Team; proactively review product complaints and address trends
Collaborate with global entities in fulfilling Field Corrective Actions (FCA) from Regulatory Field Safety Notifications
Provide relevant quality support for post-market surveillance (PMS) activities, ensure timely executions to minimize product supply interruption
Facilitate Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)
Ensure implementation of effective CAPA program across operational site
Drive 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 existing Quality Management System with Abbott QMS and Business Unit standards, conduct gap analysis, develop remediation plan, and drive to highest compliance
Manage Quality Control program for imported products distributed in the market, including final decision-making for product release and reporting for field corrective actions; collect and report product quality information
Administer and ensure compliance with major quality system activities (document control, record control, training, CAPA, quality incidents, risk management, internal audit)
Continuously drive compliance with Abbott quality standards and regulatory requirements
Manage and resolve product issues timely; coordinate cross-functionally for containment, mitigation, remediation, and corrective activities
Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of QMS impact issues, and closure of actions
Coordinate and manage site Quality metric tracking, trending, and reporting to characterize key performance indicators
Act as Commercial Quality representative for internal compliance and 3rd party audits/inspections; coordinate and manage all commercial audits with 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

Skills

Quality Management System

Regulatory Compliance

CAPA

Supplier Qualification

Audits

Post Market Surveillance

Field Corrective Actions

Quality Culture

Budgetary Planning

Change Management

Deviations

Investigations

Market Complaints

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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