GCP-Consultant (Auditing SME)

Redbock - an NES Fircroft company; United States; Remote; USD 96,000 - 193,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a GCP consultant (AD-level) to support the Audit & Inspection Management team. This fully remote assignment requires 40 hours per week with travel to Boston once monthly.

You will directly audit GCP vendors and sites, lead inspection readiness, and collaborate on SOPs and QA activities for an expanding program. The ideal candidate has 8+ years of GCP experience, strong ICH-GCP knowledge, and proven audit leadership skills, working across

Qualifications

• Minimum BS degree.
• 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.
• Demonstrated experience leading audits and supporting regulatory inspections.
• Excellent organizational, communication, and interpersonal skills.
• Ability to work independently and in a cross-functional team environment.

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

Skills

GCP auditing

Regulatory inspections

ICH-GCP knowledge

Audit program mgmt

Cross-functional collaboration

Education

BS Degree

Job description

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