Clinical -Lead, Quality Assurance

Location: Aventura, FL, United States
Date Posted: 07-12-2018
Headquartered in Miami, Florida with offices and operations across Germany, USA, Russia, Ukraine, and India; Biorasi is an award-winning, fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies.  We are looking for a dynamic, forward-thinking “game changer” to join our QA team and promote a GCP / QA philosophy thru interactions with staff on a global level.  We require an independent, confident, and highly motivated GCP / QA professional with extensive knowledge/experience of deviations, CAPA, process improvement (including SOP creation/revision), and audit experience to join our growing QA Team. They will conduct various types of internal and external audits of clinical research activities in support of global clinical trials (drug product and medical device), including monitoring quality assessments, TMF audits, project management audits, internal process audits, Clinical Study Report audits and supplier audits in any of the regions involved in Biorasi managed clinical trials. As a leader in the QA group at Biorasi, they will also participate in consultation and interpretation of regulations, development, implementation and content updates of Good Clinical Practices (GCP) and compliance training programs, identification and development of SOPs and Processes, proactive noncompliance issue identification, and escalation and management of CAPAs. 
  • Direct report to the Head of Global Quality Assurance to ensure Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines.
  • Assist in identifying needs and the planning of internal and vendor Quality Assurance audits.
  • Conduct internal, site, and vendor GCP/QA audits when directed.
  • Identify gaps, risks, and areas of continuous improvement within Biorasi’s quality systems, processes, and procedures.
  • Identification, initiation, follow up, and closure of deviations, CAPAs, and process improvements on a cross-functional level.
  • Communicate expectations and direction from Head of Quality to other Biorasi departments and locations to reduce compliance risks and improve global quality and consistency.
  • Bachelor Degree.
  • At least 4 years CRO / GCP / QA experience.
  • Experience with auditing clinical vendors, investigator sites, and internal audits. (Audit travel up to 15%.)  Auditing certification highly preferred.
  • Understanding of controlled documents, CAPAs, and Deviation Reports.
  • Practical knowledge of regulations and ICH guidelines with a focus on GCP, quality, and compliance.
  • Must be fluent in English, with superb attention to detail.
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