Emea Quality Assurance Manager - Technology Milano

Emea Quality Assurance Manager - Technology
Milano
Lombardia, Milano

Summary

We are exclusively assisting our client, a world-renowned Clinical Research Organisation (CRO) who are currently embarking on an exciting period of growth to recruit a QA Manager for the EMEA region.

The position will see you joining the dedicated Technology QA team, supporting business areas with corporate systems compliance, complex architecture, and interoperability as well as data governance and data integrity.

You will be conducting internal computerized system validation audits and vendor assessments/qualifications, supporting technology focused sponsor audits and inspections, amongst other responsibilities.

**The role

As the QA Manager you will:

- Provide cross-functional Quality Assurance expertise, supporting all areas of Technology and Information Compliance.

- Be responsible for review and approval of computerized systems validation and/or qualification to ensure documentation supports a compliant state.

- Support efforts for standardization and advancement of validation / qualification methodologies in support of software.

- Conduct internal validation audits and vendor assessments/qualifications and Support technology focused sponsor audits and inspections.

- Provide guidance to technology and information management groups to ensure the business understands applicability of associated published regulatory guidance or regulations concerning GMP, GLP, GCP, 21CFR Part 11, and Annex 11.

- Support training activities focused on advancing Systems Compliance SMEs across Quality and Compliance.

- Develop positive relationships with business unit customers to ensure a common understanding, approach and appreciation.

- Perform quality reviews of SOPs and WIs that effect the direction and process of systems compliance initiatives.

- Participate in related industry training, conferences, and professional organizations in order to keep the team current and updated with the most recent IT and computer systems best practices.

- Bachelor's degree or local equivalent in science.

- Expert knowledge with audit or inspection management.

- Experience in QA, with GxP auditing, systems compliance, and SOP development.

- Minimum 4 years of QA experience.

- An understanding of validation and qualification strategies for regulated systems including software and medical devices used in clinical settings.

- Demonstrated strength in agile working principles, methodologies, and team structures.

- Ability to travel as needed to vendor and/or internal sites.

- Experience in team management or supervisor (preferable) or a desire to manage in the future.

- Located in the Republic of Ireland, the UK or EU.

The company offer a competitive salary and benefits package that includes a comprehensive health plan, company car allowance (country dependant), retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives along with a culture that promotes and priorities career development opportunities for each employee.

**Salary**: €80, 000. 00 - €110, 000. 00 per year