| Responsible for development, implementation and QA oversight of systems and associated documenation for all phases of clinical drug development. The individual will participatge in the development of the Quality System related to GCP, GLP and Computer System Validation. ESSENTIAL FUNCTIONS: Function as a lead auditor when performing audits and authoring audit reports. Responsible for communicating audit findings and reviewing responses with clinical management or the auditee, assuring that all observations have been adequately addressed, recommending appropriate corrective and preventive action as appropriate Provide consultation on quality compliance issues to R&D Project Teams Assists the Director, CQA with special projects Participate in the maintenance of GCP, GLP and CSV auditing systems including quality planning, process improvement, SOP development, and tracking and trending audit findings Responsible for conducting follow-up audits for sites / vendors considered high risk to determine if corrective and preventive action was taken on prior audit findings Provide compliance support during regulatory inspections of the company, investigational sites or cooperative partners as applicable Provide ICH GCP training within the organization and at Investigator meetings as requested REQUIRED EDUCATION: Bachelor's Degree (Biology, Chemistry, Life Sciences etc.) REQUIRED SKILLS AND EXPERIENCE: 5+ years of experience within the Pharmaceutical or Biotech industry, including 2+ years GCP, GLP, CSV auditing experience Ability to apply quality system concepts to daily clinical operations. Strong understanding of applicable regulations (FDA 21CFR Part 11, EMEA, MHRA ICH GCP). PREFERRED EDUCATION, SKILLS AND EXPERIENCE: Master's Degree Lead auditor training certification. Hands on auditing experience. Previous people management experience. CB* BSP~ |