QA Auditor 2

hace 7 meses

Madrid, España Novasyte A tiempo completo

Join us in our exciting journey

IQVIA is expanding in SPAIN & PORTUGAL. We require a motivated, passionate, and enthusiastic professional to join our rapidly growing quality, risks & analytics department.

Job Overview

Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives. Manage the quality assurance oversight of projects, assignments, training, and staff.

Essential Functions
- Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
- Oversee and participate in the documentation, reporting, and closure of compliance issues.
- Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc.
- Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Serve as author of Quality Assurance Standard Operating Procedures ( SOPs) as assigned.
- Advise Quality Assurance management on system audit needs.
- Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.
- Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed

**Qualifications**:

- Bachelor's Degree Pref
- Experience in pharmaceutical, technical, or related area. Equivalent combination of education, training, and experience.
- GCP experience required
- Previous Site Management as CRA or quality related role is preferred
- Fluent English
- 50-75% Travel (expected)
- Location: anywhere in Europe, but preferably in Spain/Portugal
- Considerable knowledge of quality assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation skills.
- Exceptional training capabilities.
- Effective organization, communication, team orientation, and leadership skills.
- Ability to work independently with initiative.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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