Senior GCP Compliance Auditor

Summary

Join AbbVie and become a Clinical Site Auditor, primarily responsible for conducting audits of investigative clinical sites in R&D to ensure compliance. Lead investigations, communicate results, and review corrective actions. Conduct global system audits and review clinical documents for quality and compliance. Evaluate compliance risks, suggest policy improvements, and provide training and consulting services. This remote US-based role requires approximately 30% travel. AbbVie offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k). Short-term and long-term incentive programs are also available.

Requirements

• Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent experience required
• 5-7 years of pharmaceutical industry experience in Quality Assurance I Regulatory Affairs
• 5-7 years of clinical research and development
• Minimum 2 years of QA auditing experience (GCP Auditing preferred)
• Minimum of 7 years total combined experience required (not necessarily the sum of the above)

Responsibilities

• Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
• Lead investigation site audits to ensure compliance to global regulatory requirements as well as AbbVie requirements. Effectively communicate audit results, both orally and in writing
• Review corrective action plans/audit responses for adequacy and approve if adequate
• Lead Global System Audits to evaluate internal Abbvie areas for compliance to applicable SOPs and local regulations
• Review clinical research documents, such as research reports, to assess the quality and compliance to policies, procedures, and applicable governmental regulations
• Assist in periodic audits to evaluate vendor R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally
• Evaluate the potential risk of compliance deficiencies
• Review policies and procedures and suggest improvements
• Maintain effective communication of project related information
• Provide training and consulting services to the organization to ensure GCP compliance
• Assist with Clinical QA program management activities in support of studies and projects to ensure compliance with regulations, guidelines, policies, procedures and sponsor requirements

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs