GCP-Consultant (Auditing SME)
redbock an nes fircroft companyFargo (ND)
GCP-Consultant (Auditing SME)
Posted 5 days ago
redbock an nes fircroft companyFargo (ND)
SENIORITY
Senior
About the role
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-upProvide 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
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