Pharmacist- Quality Coordinator Trainee - Saudi Nationals Only

In this role you will provide support and proactive strategic planning for QA oversight of clinical development activities.You will be responsible for domestic and international clinical and vendor audits and have the opportunity to work withinternal stakeholders, have the ability to participate cross functionally, and get to use your creative problem solving skillson complex compliance issues. You’ll conduct audits, facilitate and support regulatory authority GCP inspections,preparing clinical sites. Additionally, you’ll contribute to CQA SOPs and associated documents.This will include: Participating in the evaluation and qualification of CRO’s and other service providers Conducting external and internal audits to assess compliance with GCP requirements, investigational plans andcompany standards for clinical trial‐related activities Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating withauditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes Tracking, reviewing, approving, and assessing the efficiency of CAPAs Maintaining databases for audit observations and CAPA’s Sharing responsibility with the team for the development of training materials and conducting training Assisting with the preparation, coordination, and management of regulatory agency inspectionsWhat does our ideal candidate look like?As our ideal candidate, you’ll have a university degree in science or a related field with a minimum of 5 years of relevantexperience in GCP/clinical quality assurance with a minimum of 2 years of Good Clinical Practices (GCP) auditingexperience. Global Clinical QA experience is a plus! Your areas of expertise include Phase I – Phase IV clinical trials,clinical investigator site audits, vendor audits, and ICH/GCP knowledge.You’ll possess in‐depth knowledge and clear understanding of GCP regulations and industry standards, you’ll have expertorganizational, planning and prioritizing skills, and you’ll have exceptional communication skills (written and verbal).Having worked collaboratively, including cross‐functionally, you have had demonstrated success in building andmaintaining relationships as well as influencing internal and external colleagues and collaborators. You have the abilityto present in a professional manner and write routine reports and correspondence.Ideally, you have strong computer skills in applications used in general office settings such as word processing,spreadsheet, presentation, data base management, and internet search engine applications.You bring with you strong decision‐making, situation analysis, and creative problem‐solving skills. Proven attention todetail and an orientation for meticulous work rounds out the skills we are seeking in our ideal candidate.