Senior GCP QA Auditor — Global Clinical Audits Lead

Regulatory Jobs; Durham (NC); Sur place; USD 75 000 - 189 000; Plein temps

Résumé du poste

IQVIA Quality Assurance seeks an experienced auditor to independently lead the full audit lifecycle across clinical research programs, including Investigator Site Audits, CAPA, and RCA activities. Travel 30-50% is expected.

You will collaborate with global teams, provide guidance on regulations and SOPs, and support continuous improvement in quality and compliance across IQVIA contracts. The role requires strong problem-solving, communication, and project management skills, and a track record of

Qualifications

• Experience conducting clinical trial Investigator Site Audits.
• Willingness to travel 30-50%.
• GCP experience required.
• Strong knowledge of pharmaceutical R&D processes and QA.
• Excellent communication, problem solving, and negotiation skills.
• Ability to manage multiple projects and work independently.

Responsabilités

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts.
• Evaluate audit findings and prepare reports for stakeholders.
• Provide interpretation of regulations and SOPs to teams.
• Advise on CAPA plans and RCA outcomes.
• Review and track actions from investigations and quality events to closure.
• Evaluate policies for regulatory compliance and recommend improvements.
• Perform pre-inspection site visits.
• Maintain eQMS and support audit lifecycle.

Connaissances

Audit experience

GCP experience

Interpersonal skills

Travel 30-50%

Independent work

Problem solving

Project management

Formation

Bachelor's Degree

Outils

MS Word

MS Excel

Databases

Description du poste

IQVIA Quality Assurance seeks an experienced auditor to independently lead the full audit lifecycle across clinical research programs, including Investigator Site Audits, CAPA, and RCA activities. Travel 30-50% is expected.

You will collaborate with global teams, provide guidance on regulations and SOPs, and support continuous improvement in quality and compliance across IQVIA contracts. The role requires strong problem-solving, communication, and project management skills, and a track record of