Quality Manager Middle East Abbott Laboratories

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 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.