KSA Commercial Quality Specialist

Overview

Riyadh, Saudi Arabia**Job Description:**

Overview of the role

Role Description

• Manages product quality complaints and adverse events process in liaison with franchise quality team, local commercial team, distributors and brand protection.
• Supports and cooperates in the implementation of the Field Safety Corrective Actions (FSCA).
• Conducts associated HA reporting to SFDA for product complaints and Field safety corrective actions. Has a good knowledge of health authority regulations for medicovigilance. Supports any other HA inquiries related to safety and efficacy of the product and quality related aspects.
• Act as NCMDR Officer to support SFDA communications on behalf of JnJ KSA MedTech.
• Conducts supplier and distributor audits; 3PL audits. Tracking of the follow-up activities to address observations after the audits. Work with nonconformities and CAPAs after the audits in the corporate electronic tracking systems.
• Supports supply chain/warehouse/loaner kit activities from quality perspective. Executes QA activities in warehouse system (SAP).
• Identifies deviations and raises non-conformancies, conducts investigation. Follows up and documents closure of corrective and preventive actions.
• Executes temperature excursions assessments for product release.
• Executes procedures issuance/update in case of implementation new J&J quality standards or local regulation.
• Performs risk assessments in accordance with J&J policies in applicable processes for example deviations, change controls, regulatory standards management implementation and others. Ability to take risk-based decisions to identify priorities.
• Maintains quality records in accordance with records retention policies and quality records standard, in an accurate and timely manner.
• Coordinates change control/document control initiation and approval process.
• Collect and analyze information to support in the report preparation in the quality system management review (QSMR).
• Prepares for and facilitates internal audits and regulatory/corporate inspections.
• Follows up on annual distributors/suppliers qualification and monitoring management system. Conducts supplier/distributor selection, qualification if
• needed.
• Periodically review the Regulatory Compliance System with RA team to ensure continouos 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.
• Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.

Knowledge, Skills, Competencies and Experience

• University/Bachelors Degree or Equivalent in Life Science/Engineering/Quality management.
• Fluent knowledge of English and Arabic
• Masters and/or Certifications in Quality Assurance, Project Management and innovation are a plus.
• Good knowledge of SFDA regulation;
• ISO 9001/13485 certificate (internal auditor and/or supplier auditor), IRCA certificate will be an advantage.
• SAP/warehouse management system
• Advanced analytical skills and ability to translate data and customer learning into actionable recommendations.
• Ability to set network with different stakeholders (3PL, Regulatory Affairs, Commercial & Sales, Supply Chain, HCC and others);
• Advanced communication and presentation skills as classroom and virtual trainings to big and small audiences;
• Process methodology orientation & practice;
• Microsoft Office (PowerPoint, Excel, Word, Outlook, Planner, TEAMS);
• Years of experience:
• At least 3 years of experience in healthcare (medical/pharm/hospital) industry, logistics, supply chain, quality assurance and Middle East/Africa Health Authorities Regulations.
• Process oriented individual.