Clinical Quality Manager

Overview:
Insights Research Organization & Solutions [IROS], a subsidiary of G42
Healthcare, was established in ‎2021 in Abu Dhabi. IROS is the first UAE-based
Contract Research Organization (CRO) specializing in healthcare research,
including clinical trials across all therapeutic areas, in addition to the
generation and integration of real-world data. The first of its kind research
organization in the entire Middle East, it provides international, ethical,
and scientific quality standards in clinical trial reporting, as well as key
solutions and insights that ensure access to more innovative, life-changing
treatments.

Target
* Develops oversee and manage IROS Quality Management System (QMS) including policies, procedures, guidance documents to ensure compliance with applicable laws, regulations and consistent delivery of high quality service to the clients
* Conduct/manage internal QA audits in order to assure that studies managed by IROS are on the highest standard and in compliance with applicable laws/regulations.
* Leads and/or participates in process/quality improvement processes and initiatives
Responsibilities:
* Manage company Controlled Documents system (Standard Operating Procedures SOP, Guidance Documents, and Policies)
* Effectively plan and perform/manage regular and random QA audits including but not limited to investigator site audits, vendor audits, documents, databases or internal systems in compliance with GCP and IROS policies and procedures
* Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to senior management and regulatory authorities
* Lead GCP health authority inspections and client external audits; lead clinical development teams in preparation for announced audits/inspections and provide GCP compliance support during audits or inspections of investigator sites and IROS. Facilitate appropriate and timely audits/inspection responses and follow up actions
* Oversee/manage company training programs and documentations including regular GCP trainings, regulatory trends/updates and company required trainings
* Keep abreast of regulatory updates and lead improvements processes; communicate information to staff either through training programs or other communication channels
* Participate in due diligence activities and process improvement initiatives as requested by management
* Drive growth and organizational change within the Quality Assurance department to meet corporate business goals
Qualifications:
* Life Science Bachelor's Degree required
* Master's Degree preferred7+ years of quality-related experience and proven auditing experience in the Contract Research Organization or Pharmaceutical Industry
* ‎5+ years of demonstrated successful team and/or department leadership