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Manager, Quality (GCP)Forest Laboratories - Alameda, CA* Work in association with the Clinical Department to ensure that phase I through phase III clinical trials are compliant with SOPs, FDA regulations, and ICH/GCP guidelines. * Perform and coordinate internal and external (both domestic and international) GCP-related audits; and ensure implementation of compliance systems to assure compliance with Cerexa, Inc. Standard Operating Procedures, FDA regulations, ICH guidelines, and relevent local/regional regulatory standards. * Perform and coordinate GCP-related vendor audits to qualify their use in the conduct of clinical and non-clinical studies. * Mentor and manage the activities of internal and external quality personnel. * Work closely with company personnel to ensure appropriate steps are taken to address audit findings/observations of nonconformance...originally from PharmaDiversityJobBoard.com - More Tools...
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