• Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates
• Understanding of how to plan, prepare and conduct GCP audits independently
• Proficient in authoring and managing audit documents independently
• Develop CAPA plans and contribute to resolution of audit findings independently
• Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently
• Assists in other duties relating to overall compliance within Quality and Compliance department, as requested
• Must be willing to travel up to 30% of the time for audits within the UK/EU
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Requirements:

• College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
• Minimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred
• Good communication skills and willingness to work with others to clearly understand needs and solve problems
• Excellent problem-solving skills
• Good organizational and communication skills
• Proficient with 21 CFR Part 11, FDA, and GxP requirements
• Expertise within CROs and scientific and clinical data/ terminology, and the drug development process
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