# CAPA Management Lead

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Madrid-Spain/Sr-Quality-Auditor--CAPA-Centre-of-Excellence_R1568354?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_a56a977d-60b

## Description

We are seeking a CAPA Management Lead to join our team. As a CAPA Management Lead, you will lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses.

**Key Responsibilities:**

- 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 areas of improvement

- Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS)

- Promote a culture of proactive and continuous process improvement

- Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff

- Develop and/or provide training and guidance on Root Cause Analysis (RCA), CAPA management, execution, 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

**Requirements:**

- Extensive and demonstrable experience in GCP Quality Assurance within clinical trials

- Prior audit and inspection management/support experience within a GCP-regulated clinical trials environment

- Hands-on experience conducting root cause analyses and quality investigations related to clinical trial activities

- Proven experience reviewing, authoring, managing, and driving CAPAs to closure within a GCP clinical research environment

- Strong understanding of the end-to-end clinical trial lifecycle

- Demonstrated experience managing complex quality and compliance issues

- Bachelor's Degree in a Life Sciences, Healthcare, Pharmacy, Nursing, or related scientific discipline

- Excellent problem-solving, risk assessment, and root cause analysis skills

- Proven ability to train, mentor, and advise stakeholders on GCP quality and compliance requirements

## Skills

### Required
- GCP Quality Assurance
- CAPA management
- Root Cause Analysis
- Clinical trials
- Quality management

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Madrid-Spain/Sr-Quality-Auditor--CAPA-Centre-of-Excellence_R1568354?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)