Quality Manager Middle East

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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

Were 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 Abbotts diagnostics instruments providing lab results for millions of people.

As Quality Manager youll 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 Youll 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 escalate 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

• Associate Manager Quality: at least 4 years experience
• Manager Quality: at least 7 years experience
• Senior Manager Quality: Proven long experience in the diagnostic industry preferably at a commercial affiliate with Abbott.

• 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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

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