Senior GCP CAPA Lead - Quality Assurance

IQVIA; Madrid; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Senior CAPA Quality Assurance professional to lead and oversee CAPA management for significant quality issues, audits and inspections in a GCP environment. You will assess investigations, drive root cause analysis, implement robust corrective and preventive actions and ensure timely closure.

You will mentor CAPA teams, collaborate with cross-functional stakeholders, support internal and external audits, and maintain state-of-readiness of IQVIA facilities and systems while

Qualifikationen

• Extensive GCP Quality Assurance experience in clinical trials with CAPA expertise.
• Experience in audit/inspection management within a GCP environment is required.
• Proven ability to conduct root cause analyses and drive CAPA closure.
• Strong understanding of end-to-end clinical trial lifecycle and regulatory oversight.
• Ability to train and advise stakeholders on GCP quality requirements.

Aufgaben

• Lead and mentor CAPA management team focusing on improvement and compliance.
• Oversee CAPA activities for complex QIs and sponsor audits/inspections with timely actions.
• Collaborate with cross-functional stakeholders to identify process gaps and improvements.
• Ensure CAPAs are documented in the eQMS and tracked within timelines.
• Promote proactive process improvement and risk identification across CAPA systems.
• Provide training on RCA, CAPA management, documentation, and compliance.

Kenntnisse

CAPA management

GCP QA

Risk assessment

Root cause analysis

Training & mentoring

Ausbildung

Bachelor's degree in Life Sciences or related

Tools

eQMS

Jobbeschreibung

IQVIA is seeking a Senior CAPA Quality Assurance professional to lead and oversee CAPA management for significant quality issues, audits and inspections in a GCP environment. You will assess investigations, drive root cause analysis, implement robust corrective and preventive actions and ensure timely closure.

You will mentor CAPA teams, collaborate with cross-functional stakeholders, support internal and external audits, and maintain state-of-readiness of IQVIA facilities and systems while