Senior CAPA Lead - Quality & Compliance Excellence

IQVIA; Lisboa; Presencial; EUR 70 000 - 90 000; Tempo integral

Resumo da oferta

IQVIA seeks a CAPA-focused Quality Assurance leader to oversee corrective and preventive actions for significant quality issues and inspections. You will mentor the CAPA team, drive compliant investigations, root cause analyses and effective actions, while coordinating with cross-functional partners to improve processes and ensure inspection readiness.

The role requires strong leadership, 7+ years QA experience in pharma/GCP settings, and excellence in documentation, risk assessment and

Qualificações

• Bachelor's Degree
• Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for the conduct of clinical trials
• 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 CAPA management team, driving improvement and compliance
• Lead and support CAPA activities for complex QIs and sponsor audits/inspections
• Collaborate with cross-functional stakeholders to identify process gaps and ensure CAPA adherence
• Ensure proper reporting of CAPAs in the eQMS and track actions
• Promote proactive process improvement by identifying risks and trends
• Lead with teamwork to ensure effective communication among stakeholders
• Develop/train on RCA, CAPA management, documentation practices and compliance
• Develop/improve governing procedures and work instructions to streamline processes
• Advise QA management on system audit needs
• Support external and internal audits and inspections, ensuring inspection readiness

Conhecimentos

CAPA Management

GCP guidelines

Root cause analysis

Audit support

Quality investigations

Leadership

Project management

Formação académica

Bachelor's Degree

Descrição da oferta de emprego

IQVIA seeks a CAPA-focused Quality Assurance leader to oversee corrective and preventive actions for significant quality issues and inspections. You will mentor the CAPA team, drive compliant investigations, root cause analyses and effective actions, while coordinating with cross-functional partners to improve processes and ensure inspection readiness.

The role requires strong leadership, 7+ years QA experience in pharma/GCP settings, and excellence in documentation, risk assessment and