IT & Digital Quality Assurance Manager

Contenu de l'offre IT & Digital Quality Assurance Manager chez Ipsen

IT & Digital Quality Assurance Manager

Title:

IT & Digital Quality Assurance Manager

Company:

Ipsen Pharma (SAS)

Job Description:

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
Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.

Summary

Location: Boulogne

Type: Full time