Commercial and Distribution Quality Lead

JOB DESCRIPTION:

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream.
• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.

The Opportunity
Our molecular division delivers best-in-class innovative testing solutions for people around the world providing answers to lifes critical health decisions. We help people live full and healthy lives through our accessible molecular-based solutions.

Position:Commercial and Distribution Quality Lead
Location:Abbott Laboratories Pte 3 Fraser Street 23 - 28 Duo Tower Singapore 189352

Role Overview:

Our location in Abbott Laboratories Pte Singapore is hiring a Commercial and Distribution Quality Lead. This role will be responsible for ensuring that the South Asia commercial affiliate implement and maintain cost effective quality system solutions and remain in compliance with regulatory requirements fulfilling the commitments of the region/division or corporate compliance plans. Throughout establishing and maintaining quality assurance programs policies processes procedures and controls regarding:

• Quality Management System
• Training related to the Quality System and GMP
• Change Controls Exceptions and CAPA
• Quality Events Handling Complaints Product Actions Significant events & Counterfeiting Tampering Diversion and Product Theft
• Supplier Management
• Quality Audit Program
• Material Control
• Risk Management
• Process and Gross Margin Improvement Projects

What Youll Work On:

• Improves and maintains the quality system in the area of South Asia Pacific.
• Ensures training and development for functional area is provided and documented.
• Prepare country organizations for division level corporate and external quality system audits. Continuous consideration of process improvements and implementation.
• Responds to all Division/Area audit findings with proposed corrective and preventive actions within defined period follows up on the implementation and effectiveness of actions taken.
• Perform and support the evaluation and maintenance for Supplier and Distributor management.
• Ensures compliance to local regulations.
• Provides quality oversight for the Singapore Distribution Center.
• Conceptualizes processes for labeling performed in the Singapore Distribution Center and ensures that the process is compliant and meets both Abbott and local regulatory compliance requirements.
• Provides oversight and advice for quality related issues for material control supply chain and transportation.
• Responsible for the initial evaluation and documentation of spare part depots and refresh centers in the South Asia Pacific.
• CAPA SME within the Molecular Diagnostics area commercial affiliates including One Abbott Commercial Affiliate workstream group representative.
• Act as coordinator between QA Des Plaines local Molecular Diagnostics countries and Core Diagnostics Quality Representatives for complaint related tasks such as Field Action communication Field Advisory Notices and related effectiveness checks and participate to the execution of required customer communications.
• Actively support country organizations customers and distributors with appropriate answers in all quality related questions.
• Supporting Commercial Area Management Review and document the outcome.
• Identify and escalate the potential quality risks.
• support product- and cost improvements new product launches and transfers.
• Implementation and maintenance of operating procedures relevant to Commercial and Distribution QA within South Asia Pacific.
• Lead projects and continues improvement initiatives.
• Communicates and co-operates with co-workers other departments and other
• Abbott divisions as needed and manages indirect report.

Required Qualifications:

• Education: Bachelors Degree in a related discipline.
• Experience:
  • Minimum of 4 years experience in regulated industry.
  • Excellent knowledge of the Quality System with understanding of the CAPA system and interrelated systems with an awareness of current processes and procedures as it relates to MDx Quality System and CAPA system.
  • Must be able to influence inspire coach and advise people on all Quality relevant aspects while complying with all policies and procedures of the Quality System impacting the commercial affiliates.
  • Fluent oral and written English.
  • Strong leadership communication and organization skills.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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