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