Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Job Title

QMS Lead -Global Commercial Quality & US Commercial Quality Lead

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. You’ll also have access to:

· Career development with an international company where you can grow the career you dream of.

· Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical 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 bachelor’s 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 location in Lake Forest, IL currently has an opportunity for a QMS Lead -Global Commercial Quality & US Commercial Quality Lead. The QMS Lead -Global Commercial Quality & US Commercial Quality Lead has two key roles to play- Leading the QMS for the ID Global Commercial Quality Organization and Managing the Commercial Quality operations for the US market.

WHAT YOU’LL DO

QMS Lead role: Provide strategic and functional Quality System oversite to the Commercial Quality team that ensures compliance to applicable quality, regulatory, applicable GxP regulations and Abbott procedures. requirements. This job function has accountability for complying with the applicable elements of the Corporate Quality Management System (QMS).

Commercial Quality Operations role: Responsible for implementing the Quality and Regulatory requirements; driving compliance to Abbott Global Quality/Regulatory Framework, Business Unit Policies/ Procedures, and managing the quality operations for the US market as part of the regional team.

QMS Lead Role

• Responsible for leading Global Quality Systems for the ID Commercial Quality team with direction from the Corporate Quality Systems and Business unit Quality Systems teams.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Ensure compliance for the Global Commercial Quality teams with applicable policies, processes, and procedures, contributing to the development of strategies and oversight of the QMS at the affiliates.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility to understand, maintain, and drive awareness of the quality consequences which may occur from the improper performance of their specific job.
• Responsible for developing, implementing, and maintaining the effectiveness of the quality system
• Owner of the Management Review process and related metrics tracking and trending. (Quality Documentation, Training and Supplier /Distributor Quality).
• Drive implementation of policies and procedures to maintain compliance to global regulatory requirements for policies, processes, and procedures.
• Responsible for quality oversight in the area of GxP document management and retention.
• Manage broad and cross-functional quality programs, initiatives and organizational change related to the Commercial Quality.
• Responsible for Training and for the establishment, administration, and maintenance of a Commercial Quality training program.
• Responsible for Documentation strategy and for administration and maintenance of documentation control quality programs such as: Document Change Control, Document Retention, etc.
• Responsible for Supplier Quality and for the establishment, administration, and maintenance of a supplier quality programs such as: CAPA system oversight, Supplier Quality Management and Supplier Qualification.
• Responsible for Audit schedule management, Approved Distributor and Supplier list maintenance.
• Establish and overs