Commercial and Distribution Quality Lead at Abbott

Singapore

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Expertise in Quality Management System, GMP training, Change Controls, Exceptions, CAPA handling, Complaints, Product Actions, Significant events, Counterfeiting, Tampering, Diversion, Product Theft, Supplier Management, Quality Audit Program, Material Control, Risk Management, and Process/Gross Margin Improvement Projects
Ability to ensure compliance with regulatory requirements and local regulations
Experience in preparing organizations for division-level, corporate, and external quality system audits
Knowledge of supplier and distributor management evaluation and maintenance
Capability to provide quality oversight for distribution centers, material control, supply chain, and transportation
Skills in conceptualizing compliant labeling processes
Role as CAPA Subject Matter Expert (SME) within Molecular Diagnostics commercial affiliates
Ability to coordinate between QA teams, local countries, and quality representatives for complaint-related tasks

Responsibilities

Improve and maintain the quality system in South Asia Pacific
Ensure training and development for functional areas is provided and documented
Prepare country organizations for division-level, corporate, and external quality system audits, with continuous process improvements
Respond to audit findings with corrective and preventive actions, follow up on implementation and effectiveness
Perform and support evaluation and maintenance of Supplier and Distributor management
Ensure compliance to local regulations
Provide quality oversight for the Singapore Distribution Center
Conceptualize processes for labeling in the Singapore Distribution Center to meet Abbott and local regulatory requirements
Provide oversight and advice for quality-related issues in material control, supply chain, and transportation
Conduct initial evaluation and documentation of spare part depots and refresh centers in South Asia Pacific
Act as CAPA SME and representative for One Abbott Commercial Affiliate workstream group
Coordinate between QA Des Plaines, local Molecular Diagnostics countries, and Core Diagnostics Quality Representatives for complaint tasks, including Field Action communication, Field Advisory Notices, effectiveness checks, and customer communications
Actively support country organizations, customers, and distributors with quality-related answers

Skills

Quality Management System

Regulatory Compliance

Quality Assurance

Training Programs

Quality Policies

Quality Procedures

QMS

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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