IT Quality Assurance Manager
il y a 3 jours
About Ipsen Pharma (SAS)
Ipsen Pharma (SAS) is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people's lives.
We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.
Job Summary
The IT Quality Assurance Manager - Digital Transformation will be responsible for establishing and maintaining the Digital Quality Management system (QMS) in accordance with regulations. This role will drive the execution of the Digital QMS and ensure adherence to the computer system validation principles throughout the entire system's lifecycle.
Main Responsibilities
QMS
- Ensure Digital QMS is established and updated with latest regulations and industry best practices
- Drive QMS improvements based on internal and external benchmarking
IT and Digital QA activities
- Support the execution of the Digital roadmap by providing IT and Digital QA support
- Ensure periodic review of systems including suppliers' status
Validation activities
- Assess system risks and criticality
- Determine validation strategy and deliverables
Digital supplier management
- Perform Digital suppliers' assessment
- Ensure each Digital supplier is properly assessed, depending on criticality
HA inspection and audits support
- Ensure preparation of inspections and audits of IT systems, follow up on CAPAs
Requirements
To be considered for this role, you must have a degree in computer sciences coupled with extensive experience in IT computerized system validation and associated QMS management within the pharmaceutical industry, demonstrating a value-add capability and mindset. You will have exceptional communication and influencing skills in French and English.
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