Sr. Quality Auditor, CAPA Centre of Excellence

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.

• Bachelor's Degree.
• Extensive knowledge of CAPA Management, GCP guidelines, and relevant clinical trial regulations.
• Prior experience in audit and inspection management/support.
• Skills in root cause analysis and quality investigations.
• Ability to independently manage complex quality issues.
• Experience reviewing and driving CAPAs to closure.
• 7 years of Quality Assurance experience in pharmaceutical or related areas focusing on GCP in Clinical Trials.
• Background in science, healthcare, or related discipline with detailed understanding of clinical trial processes.
• Strong leadership and organizational skills.
• Excellent problem solving and root cause analysis skills.
• Excellent training and mentoring capabilities.
• Ability to manage multiple projects independently in a fast-paced environment.
• Effective communication skills in one-to-one and group settings.
• Proficient in Microsoft Office applications (Word, Excel).

• Lead and mentor CAPA management team members to ensure compliance with regulations and guidelines.
• Lead and support CAPA activities for complex quality issues and sponsor audits and inspections.
• Collaborate with cross-functional stakeholders to identify process gaps and improvements.
• Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS).
• Promote continuous process improvement by identifying risks and optimizing CAPA processes.
• Facilitate effective communication among department stakeholders and staff.
• Develop and provide training and guidance on Root Cause Analysis (RCA), CAPA management, and compliance.
• Develop and improve procedures, templates, and work instructions to streamline processes.
• Advise Quality Assurance management on system audit needs.
• Support external and internal audits and inspections, ensuring inspection readiness.

IQVIA maintains a zero tolerance policy for candidate fraud. False statements or omissions will result in disqualification or termination in accordance with applicable law.