Contract Manager GCP Auditing position – Remote

Contract Manager GCP Auditing position – Remote 6 month contract, hourly pay, *****W2 only, no 3rd parties*** Description Top East Coast pharma is looking to hire a contractor to help build, partner and implement quality auditing activities. Must have solid Good Clinical Practice (GCP), international regulations to the auditing process to independently address GCP compliance issues. Strong knowledge of the FDA and EU regulations and ICH guidance documents for drug development and post-authorization safety monitoring. Will conduct multiple audit typeslike process, vendor, site, and license partner, depending on the requirements of the GCP subject area. Daily responsibilities include: End to end audit process, scheduling, conducting, preparing, reporting and follow up on routine and directed audits in support of the GCP (Investigator Site, Service Provider and internal process) as directed and aligned with standard operating procedures and quality policies. Conduct Internal audits and external audits globally. Represent department for complex compliance projects and initiatives both within and across functional areas or other departments. Support clinical studies as a strategy representative to develop and implement risk-based audit programs for assigned studies (GCP). Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered. May assist with training/orientation/mentoring of new department staff. Participate in regulatory inspections by acting as part of the control and inspection room team. Required: • BS and 5+ years of relevant industry experience and 3+ years of direct GCP audit experience. • Must have experience with FDA and EU regulations and ICH guidance documents.