Descrição
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.
IROS is looking for a proficient and experienced Manager - Clinical Quality to drive the overall 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
The opportunity
As a part of your role, you will conduct and manage internal QA audits in order to assure that studies managed by IROS are on the highest standard and in compliance with applicable laws and regulations.
Responsibilities:
Reporting the Director of Clinical Operations, you will lead and participate in process & quality improvement processes and initiatives.
- 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
Skills and attributes for success
- Excellent communication skills to effectively influence all levels of organization in diverse situations including conflict resolution and problem solving
- Extensive knowledge of industry regulatory requirements, and GCP
- High level of computer expertise including standard programs, an understanding of IT as related to security and quality systems
- Good comprehension of risk management strategies and business principles. Demonstrated experience in negotiation and persuasion skills
- Demonstrated ability to make sound judgments/decisions
- Excellent written and verbal communication skills, including presentation and analytical reporting
Qualifications:
To qualify, you must have
- Life Science Bachelor's Degree required
- Master’s Degree preferred
- 7+ 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
- Current education or training related to quality management in clinical trials and/or membership of a quality-focused organization
Ideally, you’ll also need
- ICH-GCP and Quality certification
What we look for:
If you are a performance-driven, inquisitive mind with the agility to adapt to ambiguity, you will fit right in. You should be eager to explore opportunities to build meaningful collaborations with stakeholders and aspire to create unique customer-centric solutions. Bias for action and a passion to conquer new frontiers in the AI space is at the heart of the G42 community.
What working at G42 offers:
Culture: An open, diverse and inclusive environment with a global vision that encourages personal growth and focuses on ground-breaking, industry-first innovations.
Career: Outstanding learning, development & growth opportunities via structured training programs and innovative, high-tech projects.
Work-Life: A hybrid work policy to strike the perfect balance between office and home.
Rewards: A competitive remuneration package with a host of perks including healthcare, education sup