GCP-Consultant (Auditing SME)

Our client is a leading biopharmaceutical company and needs a GCP consultant (AD-level) to support the Audit & Inspection Management team. This consultant will support an ongoing audit program and provide immediate support to a team that is stretched thin.This is a fully remote assignment, with travel once monthly to Boston. 40 hours a week. ResponsibilitiesDirect audits of GCP vendors, investigator sites, and internal processesLead and support inspection readiness activities, including preparation, execution, and follow-upProvide support for due diligence and business development activities as neededCollaborate in the review and development of SOPs and work instructionsEvaluate audit responses, including corrective and preventive actions, for adequacy and effectivenessContribute to process improvement initiatives within the QA functionPartner with cross-functional stakeholders to support quality assurance activities across the organizationQualifications:BS Degree minimumMinimum of 8 years of relevant GCP experience in clinical quality, auditing, or inspection managementStrong knowledge of ICH-GCP guidelines, FDA regulations, and global regulatory requirementsProven experience leading audits and supporting regulatory inspectionsExcellent organizational, communication, and interpersonal skillsAbility to work independently and in a cross-functional team environment