CAPA Excellence Lead – Quality Assurance

IQVIA Argentina; Madrid; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Senior Quality Assurance CAPA lead to manage CAPA processes for QIs, audits and inspections within a clinical trials context. You will ensure root cause analysis, corrective and preventive actions, and effective oversight in accordance with GCP regulations.

You will mentor the CAPA team, collaborate with cross-functional stakeholders, and drive continuous process improvement while maintaining inspection readiness and robust documentation in the eQMS.

Formación

• Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for the conduct of clinical trials is a must.
• Prior experience in audit and inspection management/support.
• Root cause analysis and quality investigations.
• Able to independently manage complex quality issues with minimal supervision.
• Experience reviewing and driving CAPAs to closure.
• 7 years Quality Assurance experience in pharmaceutical, technical, or related area with a focus on GCP in Clinical Trials.
• Background in science, healthcare and/or other relevant discipline and a detailed understanding of the clinical trial process and GCP guidelines.
• Possess strong leadership and organizational skills for prioritizing workload and responsibilities.
• Excellent problem solving and root cause analysis skills.
• Excellent training and mentoring capabilities.
• Ability to handle multiple projects and work independently and effectively in a fast-paced changing environment.
• Ability to speak effectively one-to-one, in group settings, with clients, vendors and employees of the organization.
• Proficient in Microsoft Office applications (Word, Excel).

Responsabilidades

• Lead and mentor members of the CAPA management team, with a focus on driving improvement and compliance.
• Lead and support CAPA activities for complex QIs and sponsor audits and inspections.
• Collaborate with cross-functional stakeholders to identify process gaps and ensure application of quality processes.
• Ensure proper reporting and documentation of CAPAs in the eQMS and that actions are tracked within timelines.
• Promote a culture of proactive and continuous process improvement by identifying risks and trends.
• Lead with teamwork to ensure effective communication among stakeholders and staff.
• Develop and/or provide training on RCA, CAPA management, good documentation practices, and compliance adherence.
• Develop and/or improve governing procedures, templates and work instructions.
• Advise Quality Assurance management on system audit needs.
• Support external and internal audits and inspections and ensure inspection readiness.

Conocimientos

CAPA Management

GCP Guidelines

Audit & Inspection

Root Cause Analysis

Quality Investigations

Leadership

Mentoring

Project Management

Communication Skills

Training & Mentoring

Multitasking

Independent Working

Office Proficiency

Educación

Bachelor's Degree

7 years QA experience in pharma/GCP

Science/Healthcare background

Herramientas

Microsoft Office

Excel

Word

Descripción del empleo

IQVIA is seeking a Senior Quality Assurance CAPA lead to manage CAPA processes for QIs, audits and inspections within a clinical trials context. You will ensure root cause analysis, corrective and preventive actions, and effective oversight in accordance with GCP regulations.

You will mentor the CAPA team, collaborate with cross-functional stakeholders, and drive continuous process improvement while maintaining inspection readiness and robust documentation in the eQMS.