Commercial Quality Senior Specialist

Job Description Middle East Medical Devices Commercial Quality Senior Specialist Overview Quality System Specialist performs quality support duties including maintenance of the corrective action and preventive action (CAPA). Provides support for special quality projects. Ensures and maintains a state of inspection readiness. Establishes and maintains quality assurance programs, procedures, and controls, ensuring that performance parameters of the quality system elements are continually measured to drive improvement initiatives. Location Riyadh, Saudi Arabia Reporting To UAE DC QC Head Role Description Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner. Coordinates change control documentation and approval process. makes proposals and assists in the development of corrective action plans and monitors implementation. Follows up and documents closure of corrective and preventive actions. Manages product quality complaints and Adverse events process in liaison with franchise quality team, local commercial team and brand protection. Collect and analyze information from different quality management systems to support in the QMS periodic review process. Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time. Prepares for and facilitates internal audits and regulatory/corporate inspections. Implement compliance training management system for the whole Middle East Organization using effective computer system and provide with periodic trend analysis and evaluation. Follows up on annual distributors/suppliers qualification and monitoring management system. Supports and cooperates in the implementation of the Middle East Field safety Corrective Actions systems. Periodically review the Regulatory Compliance System with RA team to ensure continuous compliance with all effective local regulations. Monitors trends, identifies issues, recommends and implements appropriate actions. Assists in the development, implementation and review of standard operating procedures for interactions with contract manufacturers. Qualifications Knowledge, Skills, Competencies and Experience Education: (minimum required for competent performance in this position) University/Bachelors Degree or Equivalent in Life Science/Engineering. Masters and/or Certifications in Quality Assurance, Project Management and innovation are a plus. Skill Sets and Competencies: Advanced analytical skills and ability to translate data and customer learning into actionable recommendations. Interdependent partnering skills with multi-task capacity. Advanced communication and presentation skills Process methodology orientation & practice Strong IT skills including Microsoft Office package Years of experience: (minimum required to be able to handle the position) 5 years of experience in healthcare industry quality and Middle East/Africa Health Authorities Regulations. Process oriented Individuals are required. Compliance Statement § Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority. § Complies with own training requirements to perform duties of own job. Required Business & Leadership Or Technical Experiences – Leadership behaviors required Strategic Thinking Outward looking-Customer centric Business and results driven Interdependent partnering ability Prudent risk taking This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Primary Location Saudi Arabia-Ar Riyad-Riyadh- Organization Johnson & Johnson Medical Saudi Arabia Ltd Legal Entity for [Medical devices] Job Function Quality Requisition ID 2105992744W