Oversees the Clinical Quality Assurance department to ensure quality oversight of phase I-III domestic and international clinical study trials and GCP related systems and processes. This position will ensure, through audits and interactions with vendors, investigator site and Clinical Operations that all Morphotek clinical trials are conducted in accordance with applicable government regulations, federal guidelines, company standard operating procedures and industry standards.
Oversight of all clinical quality assurance functions. Considerable decision making capability with regard to ensuring quality is built into clinical trial processes
• BA/BS degree in biological Sciences, Nursing or related discipline
• Experience and knowledge of Code of Federal Regulations, 21 CFR Parts 11, 50, 54, 56 and 312, European Directives, Good Clinical Practices (GCP) and ICH guidelines
• At least 10-15 years' experience in the management and oversight of clinical audit plans and Clinical Quality Assurance audits
• Personal qualities will include diplomacy & assertiveness with good persuasion skills and an organized & detailed approach to work. An effective decision maker with excellent communication & interpersonal skills to cultivate the awareness & attitude towards quality issues which is key to the company's continued success
• Effective strategic thinking and planning skills, the ability to operate effectively within a busy team, and build influential relationships both internally and externally
• Strong customer service focus.