Sr. Manager, GCP Audit & Training

DUTIES AND RESPONSIBILITIES This position designs, develops, implements, directs and/or conducts the training and manages and/or conducts audits of clinical sites, CROs and testing laboratories to assure compliance with GCP and GXP in the U.S. and internationally. Manages GCP Compliance activities for domestic and international research project(s) including, but not limited to, the following: Audits clinical and preclinical research procedures and internal systems Audits clinical and preclinical trial data and reports Audits clinical investigator sites, preclinical laboratories, clinical and preclinical contract facilities including personnel qualifications, computerized systems, and standard operating procedures to assess validation and compliance with applicable domestic and international regulations, guidelines, guidances, and expectations. Provides clinical compliance guidance and consultation to senior management. Establishes and implements a GCP/GXP training plan. Directs and/or conducts formal GCP trainings. Designs, develops and/or harmonizes GCP and GLP systems as needed. Has overall responsibility for managing interactions with internal product development teams and Contract Research Organizations (CROs) related to the planning and conduct of GCP and GLP activities for preclinical and clinical research projects/trials. Maintains up-to-date, in-depth operational knowledge of worldwide GCP and GLP regulatory guidances and industry best practices. Acts as internal expert and advises management of key developments, their implications to Dey and designs, develops and proposes plans to assure compliance. Implements or oversees implementation of approved plans. Directs and/or conducts the GCP/GXP audit activities of CROs. Establishes budget and manages expenses. For each clinical and preclinical/toxicology study, establishes and implements an audit plan to assure compliance with GCP/GXP worldwide. Serves as a member of the Product Development Teams. Reviews and approves clinical and toxicology study plans and task orders. REQUIRED EDUCATION/EXPERIENCE/SKILLS Typically requires a Doctoral degree in a scientific discipline and 8+ years experience in training and audit of GCP/GXP in the U.S. and/or internationally Or a Masters degree and 12+ years experience or a Bachelors degree and 15+ years experience or equivalent. Must demonstrate dexterity in compliance principles and techniques (not just auditing) with expert working knowledge of applicable regulations, guidelines, and FDA/regulatory expectations. Requires in-depth knowledge of and broad experience in conducting clinical trials, writing and approving final FDA reports, and excellent research background and experience. DEY supports diversity in the work place. We are an Equal Opportunity Employer.