Quality Regulatory Compliance (QRC) Lead- Middle East & Africa (MEA) Region
Johnson & Johnson Middle East
مجموع سنوات الخبرة :8 years, 11 أشهر
-Responsible for Establishing J&J Quality Compliance System Framework.
-Responsible for identifying Compliance Risks and establish Corrective and Preventive Actions to mitigate potential or actual non-compliance risk.
-Establish and Track corrective action plans and mitigation/remediation plans for Audits, & Non-conformance.
-Developing, Marinating and Revising Organizational Applicable procedures, in alignment with Local Health Authorities requirements and Organization global Policies and procedure, to drive continual improvement..
-Ensure organization compliance with the applicable policies and procedures through implementing Regional Training program and induction trainings to new hires.
-Ensure the policies and procedures effective implementation in the region by conducting Periodic Internal Audits and open Corrective and Prevention Actions (CAPA) for incompliance findings.
-Develop, lead and maintain a comprehensive audit readiness program for the region to ensure internal and external compliance.
-Drive simplification & standardization of Quality Compliance System in the region, in line with Organization strategies & initiatives.
-Monitoring closely the Market trends and any emerging Regulatory and Compliance Issues that might impact the business in the region and develop local Issue Escalation process to define the timelines and the escalation channels to the Local Management and Global Leadership team, if required according to the Risk Level.
-Engaging with the organization Leadership Management Team to Review the effectiveness of Quality Compliance System and for reviewing rising compliance issues in the Region and the progress of their mitigation plans.
Role in Medical Affairs:
•Providing the necessary support in developing all Medical Knowledge & trainings for the field force for one of the company core products (Pradaxa).
•Providing the necessary support for product defense in the region and handle medical queries received from the field.
•Responsible for all formulary listing for company core products in MENA.
Role in Clinical/Observational Studies:
•Responsible for preparation of Essential Documents.
•Responsible for Source Document Verification.
•Supervising & monitoring the flow of CRF collection & completion and investigators financial contracts & payments.
•Resolve any issues or queries from Stakeholders (investigators & Contracted company CRO)
Role in Drug Safety:
•Classification & Processing of Adverse events from Post Marketing Surveillance Studies, Non-Trial Activities & Spontaneous Adverse Events for Middle East & North Africa Region (MENA).
•Key contact with Local Health Authorities for PSUR & Adverse Events reports submission for Middle East & North Africa Region (MENA).
•Responsible for Training all company staff on Pharmacovigilance to ensure Compliance according to the company policy & procedures.