The Position

Summary

The Regional Quality Specialist ensures the implementation of Roche Quality standards across our operations within Sub-region Middle East. As a dedicated quality advocate, you will collaborate with local teams to implement and maintain quality management systems, conduct thorough audits, and drive continuous improvement initiatives. By closely monitoring processes, resolving issues, and providing targeted training, the Regional Quality Specialist guarantees consistent excellence in products/services while fostering harmonious relationships with stakeholders in the sub-regional Middle East.

Quality Management Systems

• Actively drive effective mQMS implementation, assess local requirements for additional documents if needed
• Support Quality Manager/team to prepare local policies and procedures, ensure compliance to mQMS and other Roche directives
• Supports Quality Manager for External Audit, Internal Audit and conducts audit as on when required.
• Actions corrective actions and recommendations as per audit reports, internal findings, discrepancy remediation to ensure continual improvement according to Roche standards
• Lab quality Support

Post-Market Quality Support

• Monitoring the local Product Complaint Management software, ensuring compliance to Divisional Directives/mQMS and reporting guidelines and timelines
• Performing Complaint case reviews on frequent basis against local KPIs and Global KPIs, following-up and monitoring implementation of corrective actions by collaborating with Customer Support team and regional service managers to ensure complaint case documentation and best practices eg Modification code monitoring
• Monitoring the Logistic Claim KPIs and trends for quality metrics working closely with Supply Quality Manager
• Responsible for the provision and analysis of Quality System metrics upon request/for Quality Regulatory / Professional Service department meetings
• Effectively communicate with Business partners, Quality champions and local authority about post-market quality requirements

Execution of Affiliate Notification

• Receiving information/ instructions for Quality Notification (QN) / Safety Board Notification, evaluating and informing the appropriate persons within the organization within a reasonable timeframe and monitoring the feedback
• Executing, in agreement with the Regulatory & Quality Manager any QN measures/actions to be taken at a local level and, if indicated, informing or ensuring that local authorities are informed
• Execute lot restrictions/quarantine and product removal
• Lead on the regional credit reimbursement process within the region for applicable Safety and Quality Notifications, coordinating with order management, finance and RDI

Who You Are

• You hold a BA or BS degree preferably in Life Science and/or logistic related topics
• You have 3 - 5 years experience as a Quality Specialist, field technical/application support specialist
• You are familiar with Roche modular QMS, Regional Quality Management Systems and Complaint Management processes and Post-Market Quality requirements @ Roche
• You have proven track record in problem solving
• You have strong technical background of Roche products. Including CPS, RMS, IT and POC
• Preferably having Quality/Audit background
• You are a self-starter with strong organizational skills and are able to manage projects independently from start to finish
• You are a team player
• You have proven knowledge with regulations of FDA, CE, CAP , CLIA, ISO laboratory and manufacturer requirements
• Well-developed teamwork, collaboration and negotiation skills to communicate clearly and professionally both verbally and in writing.
• You have Auditing Experience / certified auditor
• You have advanced interpersonal skills and the ability to understand individual needs and motivation
• You fluent in English (verbal and writing). Arabic language, or any spoken language in the market is considered a plus
• You have excellent oral and written communication skills

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

Roche