.We are Growing! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization.Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.Your role:Lead development, implementation, and maintenance of GCP Quality Systems and SOPsTrain and mentor staff on global GCP regulations and guidance. Provide QA oversight and auditing of eTMFsLead and/or oversee consultant mediated audits; develop, recommend, andfollow up on corrective actionsLead preparations for Clinical Operations (corporate and third-party) inspection-readinessLead and manage GCP Inspections on behalf of Biorasi and Biorasi clients.Serve as an SME for areas of responsibility during regulatory inspections, and directly manage inspection Ready -Room activities.In partnership with the Clinical Operations, Regulatory, and Pharmacovigilance teams, design and implement a risk-based clinical Quality Assurance management systemIdentify QA and compliance related issues and implement solutions to ensure timelines are maintainedEstablish metrics and report the state of GCP Quality and compliance of clinical trials to senior managementEnsure Clinical Operations activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standardsProvide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study andKeep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.Ensures that Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines.Ensures that Biorasi standard operating procedures (SOPs) are compliant with applicable regulations and guidelines.Oversees the planning and conduct of internal, investigator, and vendor Quality Assurance audits.Manages the administration of Quality Assurance files and the control of central files.Your Profile:Degree in biomedical sciences, related scientific discipline.10+ years in drug development or clinical research within the pharmaceutical industry or CRO with at least three years in quality assurance, quality management, or clinical safety related area of responsibility.Strong planning, leadership, negotiation, communication, and presentation skills.Experienced with auditing clinical vendors and investigator sites. Practical knowledge of GCP or GMP, and FDA regulatory structure.Proficient with Microsoft Office tools
