(Senior) Manager– Application Validation and Quality
The (Senior) Manager– Application Validation and Quality is responsible for the day to day operations and coordination of all activities relating to the argenx Computer Systems Validation (CSV) Process.
argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development.
argenx is evaluating our lead candidate, efgartigimod, in multiple serious autoimmune indications and cusatuzumab in hematological malignancies in collaboration with Janssen, along with advancing earlier stage assets within its therapeutic franchises.
What we are looking for
For the expansion of our BIS team, argenx is looking for a (Senior) Manager– Application Validation and Quality.
The (Senior) Manager– Application Validation and Quality is responsible for the day to day operations and coordination of all activities relating to the argenx Computer Systems Validation (CSV) Process. This ranges from Initial Impact Assessment, through initial implementation, managing Saas Release validation, and solution retirement.
The position will have the following key responsibilities
- Monitor and ensure successful completion of Release Management of all argenx platforms/solutions.
- Drives (together with the appropriate functions) the planning and preparation of essential documents to a quality standard:
- Own the Computer Systems Validation SOP.
- Partner closely with the QA function at argenx to ensure alignment with all SOPs.
- Ensure CSV SOP is fully aligned with the latest guidance from EMA/FDA/PDMA.
- Ensures timely, open and effective communication to relevant stakeholders
- Teams, collaborators, management, contractual partners
- Manages external CVS partner to get a highly engaged and motivated team.
- Liaise with the appropriate BIS functions to perform the original CSV assessment, final implementation validation, AND define release management strategy for each platform.
- Support all tool audits together with the Finance audit function at argenx.
- Align GDPR, HIPAA and APPI guidelines with the Legal function at argenx.
Desired Skills and Experience
- Minimum of 5-7 years working either in or near a biopharmaceutical medical or development sciences function, either within BIS/IT and/or in a development sciences function.
- Experiences as Validation lead for computer systems in a regulated industry.
- Experience SmartSheets for project tracking.
- Understanding of the industry landscape and global regulatory requirements (e.g. GxP, HIPAA. GDPR, APPI, etc..).
- Excellent attention to detail and documentation.
- Demonstrated ability to work, effectively communicate, and influence at multiple levels within multidisciplinary organization.
- Demonstrated ability to manage external service providers and budgets.
- Demonstrated ability to monitor many project release schedules.
- Adeptness in anticipating potential areas of extra focus as identified during the CSIA phase.
- A competitive salary package with benefits;
- A work environment in a human-sized, dynamic, rapidly growing biotech company