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System Compliance Manager, Digital Systems Management, Veeva Vaults
2 maanden geleden
Genmab is seeking a highly skilled System Compliance Manager to join our Digital Systems Management team. As a key member of our team, you will be responsible for ensuring the compliance of our enterprise electronic document management system (EDMS), GenDocs, with regulatory requirements and industry standards.
The ideal candidate will have extensive knowledge of GxP systems, GAMP, IT validation, and test management. You will work closely with our QA, Legal, and IT teams to ensure the implementation of compliance requirements impacting the systems. Your expertise will be essential in developing and optimizing system processes for the operation and maintenance of GenDocs.
Key Responsibilities- Maintain system compliance documentation, including validation master plans, risk registers, and system operation SOPs.
- Lead and conduct periodic reviews and other compliance activities, such as critical user reviews and audit trail reviews.
- Review vendor compliance documents and ensure that vendors meet regulatory requirements.
- Develop and optimize system processes for the operation and maintenance of GenDocs.
- Participate in future Veeva Vault projects as Validation Lead/SME.
- Develop and optimize IT validation procedures and tools in the team.
- Bachelor's degree in a relevant field, such as Life Science, IT, or Engineering.
- At least 5 years of work experience in the pharmaceutical or biotech industry, with 1-2 years in a similar role.
- Extensive knowledge of GxP systems, GAMP, IT validation, and test management.
- Experience with EDMS systems, preferably Veeva Vault administrator and platform certification.
- Excellent communication skills in English, written and oral.
Genmab is a biotechnology company committed to building extraordinary futures together. We develop antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our company culture is built on being proudly unique, determined to be our best, and authentic.
We offer a dynamic and expanding R&D organization, with a global IT system in GenDocs based on the Veeva Vault cloud platform. Our team is passionate about our purpose and genuinely cares about our mission to transform the lives of patients through innovative cancer treatment.
