Auditor, RDQA Clinical Quality Audit - Remote

AbbVie; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical Quality Assurance Specialist focused on the execution of the Clinical audit program within AbbVie's regulated environment.

You will plan, schedule, and conduct audits at investigator sites, communicate findings, review CAPs, and contribute to the Clinical QA system. Travel up to 40% with global/remote flexibility.

Qualifications

• Bachelor’s in science or health care.
• 3-5 years in biopharma or regulatory agency.
• 3-5 years in Quality Assurance and/or Clinical Research.
• Strong knowledge of ICH-GCP, EU Clinical Trial Directive/Regulation.
• Analytical skills.
• Ability to work independently in a dynamic environment.
• Effective communication and project management skills.

Responsibilities

• Plan, schedule, and conduct audits (investigator sites, processes, systems, affiliates).
• Communicate audit findings.
• Review and approve Corrective Action Plans.
• Contribute to development of the Clinical QA quality system.
• Support GCP inspections and provide GCP compliance guidance.
• Promote ongoing education on clinical regulations.

Skills

Analytical skills

Independent working

Communication

Project management

Education

Bachelor’s in science or health care

Job description

Role

Clinical Quality Assurance Specialist focused on the execution of the Clinical audit program within AbbVie's regulated environment.

Responsibilities

• plan, schedule, and conduct audits (investigator sites, processes, systems, affiliates)
• communicate audit findings
• review and approve Corrective Action Plans
• contribute to development of the Clinical QA quality system
• support GCP inspections and provide GCP compliance guidance
• promote ongoing education on clinical regulations

Requirements

• Bachelor’s in science or health care
• 3-5 years in biopharma or regulatory agency
• 3-5 years in Quality Assurance and/or Clinical Research
• strong knowledge of ICH-GCP, EU Clinical Trial Directive/Regulation
• analytical skills
• ability to work independently in a dynamic environment
• effective communication and project management skills

High-Value

clinical audits in GCP-regulated environment, investigator sites, process and system audits, international travel up to 40%.

WorkSetup

travel up to 40%; location not specified but implied global/remote flexibility.