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Job #02577

About our client Our client is a biopharmaceutical company dedicated to discovering, developing and commercializing orally active drugs that address significant unmet medical needs. Primarily focused on the treatment of cancer and inflammatory disease, their proprietary drug development pipeline includes several small molecule drug candidates designed to regulate targets in therapeutically important biologic pathways. This company aims to be the most efficient inventor of therapeutic products in the pharmaceutical industry. Position Location Senior Manager/Associate Director, Quality Assurance Colorado Salary Highly competitive package, commensurate with experience Responsibilities 1) Establish a framework for the Clinical QA Department by establishing QA systems, audit plans and training programs 2) Develop and implement vendor oversight programs to monitor performance of clinical research activities 3) Ensure that processes, procedures and activities are in compliance with GCPs and other prevailing regulations and guidelines 4) Conduct and/or oversee audits of internal procedures, clinical study reports, CROs, clinical investigators, contract labs, SOPs and outside vendors 5) Provide Certified Quality Assurance (CQA) representation to the Project Teams 6) Assist in the creation and maintenance of CQA, SOPs and audit tools 7) Investigate and resolve compliance problems and questions regarding regulatory affairs, clinical operations, data management, statistics and safety 8) Conduct GCP training 9) Work with the CRAs 10) Conduct internal audits with regards to documentation and compliance 11) Maintain departmental training documents (SOPs, work instructions, etc.) 12) Assist with hosting regulatory agency inspections Requirements 1) MS/BS degree in a scientific discipline/Life Sciences 2) 7+ years of experience in clinical quality assurance and auditing 3) Knowledge of Good Clinical Practices (GCPs), quality systems (SOPs), and audit (procedures and reporting) 4) Ability to write effective SOPs, quality assurance reports and training materials 5) Experience in applying principals of 21 CFR Part 11 to clinical systems 6) Ability to communicate effectively and non-confrontationally with internal departments 7) Ability to develop systems and SOPs while reviewing protocols and reports 8) Capable of planning activities to meet CQA objectives 9) Ability to multi-task 10) Ability to resolve/document quality problems as appropriate and know when to elevate problems to a higher level