Clinical Qa Auditor Lazio

Clinical Qa Auditor
Roma
Lazio, Lazio

About AbbVie

- Home or Office-based in AbbVie locations across Europe

- International travel

- Comprehensive benefits package, with excellent progression opportunities

**Role Objective**:

The Clinical QA Auditor will be responsible to conduct the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits across the European, Middle East and Africa region.

Ensuring alignment with RDQA policies and procedures and advice/ support on GCP and quality topics to our business partners.

**Key Responsibilities**:

- Assures quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities

- Leads and participates in Clinical Audit scheduling, planning and conduct activities for Investigator Clinical sites, process, system and Affiliate audits.

Effectively communicates audit results, both orally and in writing, within target timeframes.

Review and approves Corrective Action Plans submitted in response to audit observations within target timeframes and tracking of actions to completion

- Advances the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements.

Supports maintenance or development of Quality standards relating to Clinical audit.

Works with Clinical Site Monitoring, Clinical Study Leadership and other Clinical Development Operations representatives on a worldwide basis as part of the audit management process

- Participates in and supports GCP inspections, as required

- Provides support and consultation to RDQA and business partners with regards to GCP regulations

- Promotes continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff

**Qualifications

- Bachelors Degree in Science, or equivalent working experience

- Clinical research development and/or clinical audit experience and clear working knowledge of ICH-GCP and other relevant standards

- Key communication skills; deliver audit findings with confidence and engage with your target audience

- Strong analytical skills and the ability to draw conclusions from presented data

- Strong team focus

- Ability to work effectively and efficiently in a dynamic environment with mínimal supervision

- Willingness and ability to perform international travel

**Travel

Yes, 25 % of the Time

**Job Type

Experienced

**Schedule

Full-time

**Job Level Code

IC

**Equal Employment Opportunity