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.
Responsibilities
Direct audits of GCP vendors, investigator sites, and internal processes Lead and support inspection readiness activities, including preparation, execution, and follow-up Provide support for due diligence and business development activities as needed Collaborate in the review and development of SOPs and work instructions Evaluate audit responses, including corrective and preventive actions, for adequacy and effectiveness Contribute to process improvement initiatives within the QA function Partner with cross-functional stakeholders to support quality assurance activities across the organization Qualifications : BS Degree minimum Minimum of 8 years of relevant GCP experience in clinical quality, auditing, or inspection management Strong knowledge of ICH-GCP guidelines, FDA regulations, and global regulatory requirements Proven experience leading audits and supporting regulatory inspections Excellent organizational, communication, and interpersonal skills Ability to work independently and in a cross-functional team environment