KSA Commercial Quality Specialist

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.