System Compliance Manager for Genmab's Enterprise Electronic Document Management System
3 weeks ago
At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.
The Role
We're seeking a System Compliance Manager to join our Digital Systems Management team, responsible for the clinical development, regulatory affairs, CMC, and QA areas in R&D. The ideal candidate will have extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management.
Key Responsibilities
- Maintain system compliance documentation during operation of GenDocs, including Validation Master Plan, Risk Register, and system operation SOPs.
- Lead and conduct periodic review and other compliance activities, such as critical user reviews, audit trail reviews, and annual system reviews.
- Have oversight of vendor compliance documents and review compliance reports from vendors.
- Liaise with QA, Legal, IT, and other Genmab departments to ensure implementation of compliance requirements impacting the systems.
- Develop and optimize system processes for the operation and maintenance of the GenDocs system.
- Participate in future Veeva Vault projects as Validation Lead/SME and develop and optimize IT validation procedures and tools in the team.
- Prepare, coordinate, and participate during audits and inspections of the GenDocs system.
Requirements
- Bachelor's degree in Life Science, IT, Engineering, or similar area.
- At least 5 years of work experience from the pharmaceutical or biotech industry, and 1-2 years' experience from a similar role.
- Extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management.
- Participated in IT GxP projects, either as project SME or Validation Lead.
- Practical work experience with EDMS systems, and preferably Veeva Vault administrator and platform certification.
- Excellent communication skills in English, written and oral.
About Genmab
Genmab is a biotech company committed to building extraordinary futures together. We're dedicated to developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.
Why Join Us
- Opportunity to work in a fast-growing, dynamic company.
- Chance to develop your competences and skills within an IT system team.
- First-hand experience of how a biotech company operates.
- Collaborative and open work environment.
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