IT & Digital Quality Assurance Manager

il y a 1 semaine

BoulogneBillancourt, France IPSEN Temps plein

**Title**:
IT & Digital Quality Assurance Manager

**Company**:
Ipsen Pharma (SAS)

**Summary / purpose of the position**
- To establish and maintain the Digital Quality Management system (QMS) in accordance with regulations.
- To drive the execution of the Digital QMS and ensure the adherence to the computer system validation principles. (CSV) throughout the entire system’s lifecycle.
- To ensure CSV of Digital systems and Software as Medical Device through QA role in Digital projects and run.
- To train, support and advise the Digital teams on regulations and CSV activities.

**Main responsibilities / job expectations**

**QMS**
- Ensure Digital QMS is established and updated with latest regulations and industry best practices
- Drive QMS improvements based on internal and external benchmarking
- Ensure implementation and execution of quality procedures throughout system lifecycle
- Promote the Digital QMS by ensuring initial and periodic training to Digital teams

**IT and Digital QA activities**
- Support the execution of the Digital roadmap by providing IT and Digital QA support
- Ensures periodic review of systems including suppliers’ status

**Validation activities**
- Assess system risks and criticality
- Determine validation strategy and deliverables
- Coordinates validation activities
- Review and approves validation deliverables
- Authorize change release to production
- Guarantee validation status for systems Go-live

**Digital supplier management**
- Perform Digital suppliers’ assessment
- Ensures each Digital supplier is properly assessed, depending on criticality
- Coordinate with procurement and supply chain on managing Digital suppliers

**HA inspection and audits support**
- Ensure preparation of inspections and audits of IT systems, follow up on CAPAs

**Knowledge, abilities & experience**

Education / Certifications:

- Master’s degree in computer science

**Experience**:

- Over 5 years in a pharmaceutical environment
- Significant experience in IT computerized system validation and associated QMS management
- Significant experience in Digital computerized system validation and associated QMS management
- Significant experience in Software as Medical Device and associated QMS management

Languages:

- Fluent in English and in French

**Key Technical Competencies Required**
- Good knowledge of regulations (GxP, FDA, ISO and other regulations)
- Good understanding of Agile models

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