Quality Manager Middle East

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You Will Have Access To

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

Quality Manager-Middle East

Our Diagnostics business is looking for an Quality Manager to support Middle East and will be based in UAE.

About Diagnostics Division

We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

As Quality Manager, you'll be responsible to-

Ensure Quality System awareness and compliance of new and revised quality documents and regulations that affect the assigned area of responsibility.

Supports the business in the affiliate / region according to the position expertise and functions.

What You'll Do-

Plan and conduct internal audits to verify the effectiveness of the management system

Prepare / coordinate external audits.

Perform supplier audits as required.

Support / provide training to the organization about the CRDx Quality System.

Ensure QS record keeping, document control, Warehousing, QH, Supplier / Distributor evaluation / monitoring, CAPA management follow up and ensure timely closure.

Coordinate Field Communications at the Region.

Ensure availability of org charts (including LSME if required) and job descriptions.

Assess risk related to processes

Timely elevate regional concerns to Area Management Review and MIMS MR

Supports Global Commercial Affiliates QA improvement projects

Maintain / challenge current certifications. Propose new certificates if required.

Coordinates communication between commercial organization and Regulatory to support responses in contracts and public tenders (e.g. QARA, EHS, Data Privacy requirements).

Team / MIMS Subject Matter Expert & Procedure Owner : Be the expert on a QS process and support the rest of team as process SME : either as lead, backup or team member.

Review Abbott policies & procedures, and update Quality documentation accordingly.

Manage any audit input by initiating changes to affected processes following MIMS change control procedures.

Identify and coordinate improvement initiatives within the entire QS.

Participates in Quality System improvements and implementation projects

Actively seek internal / external customer feedback and respond to issues

If there is no regulatory function in the affiliate, perform / ensure revision and approval of locally / translated AdPromo material on behalf of Regulatory Affairs. If needed, support RA appointing language approvers and ensure trainings are done accordingly.

Manage the QA budget, always considering cost improvement opportunities.

Manager Quality only :

Act as an expert for sales and customer support for accreditation topics, presentations, and process implementation in sites where customer certification / accreditation is requested.

Required Qualifications :

Scientific background (i.e. Lab Technician, Biology, Chemistry, Pharmacy, M.D.) is preferred. Other education (i.e. business, engineer) is acceptable if experience of 3 or more years in similar manager position.

Background

Managers can have experience in one or several of the following :

Quality Assurance in a commercial affiliate at the IVD / MD / pharmaceutical industry is preferred, either as manager or as specialist, for at least 3 years.

Regulatory Affairs, Customer Service or any other commercial affiliate function at the diagnostic / medical device / pharmaceutical industry,

Manufacturing / Distribution / Clinical laboratory / Competent Authority / IVD / MD / Pharma industry association

This is the experience expected for each category,

Product and market environment knowledge preferred.

Management skills and leadership competencies

English negotiation skills. Other language skills desirable.

Experience to work in international environment, project management and negotiation skills desirable.

Impact of position

Operates under Quality and Regulatory directives and Abbott policies and procedures.

Follows local regulations, European guidelines, and International Industry / Quality System standards.