System Compliance Manager
3 weeks ago
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 electronic document management system (EDMS), GenDocs, with regulatory requirements and industry standards.
The successful candidate will have extensive knowledge of GxP systems, GAMP, IT validation, and test management. You will work closely with our QA, Legal, and IT departments to ensure the implementation of compliance requirements impacting the systems.
As a System Compliance Manager, you will be responsible for maintaining system compliance documentation, leading periodic reviews, and conducting audits and inspections of the GenDocs system. You will also participate in future Veeva Vault projects as a Validation Lead/SME and develop and optimize system processes for the operation and maintenance of the GenDocs system.
Responsibilities- Maintain system compliance documentation, including validation master plans, risk registers, and system operation SOPs
- Lead and conduct periodic reviews and audits of the GenDocs system
- Review vendor compliance documents and ensure implementation of compliance requirements
- Develop and optimize system processes for the operation and maintenance of the GenDocs system
- Participate in future Veeva Vault projects as a Validation Lead/SME
- 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.
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System Compliance Manager
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab 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 electronic document management system (EDMS), GenDocs, with regulatory requirements and industry standards.The successful candidate will have extensive...
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System Compliance Manager
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout GenmabWe're a biotech company committed to developing innovative cancer treatment and serious disease therapies. Our mission is to build extraordinary futures by pioneering therapies that change lives.The RoleWe're looking for a skilled System Compliance Manager to join our Digital Systems Management team. This team supports and develops IT systems,...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab 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 IT compliance of our GenDocs system and associated business processes.The ideal candidate will have extensive knowledge of GxP systems, GAMP, IT validation, and test...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab 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 IT compliance of our GenDocs system and associated business processes.The ideal candidate will have extensive knowledge of GxP systems, GAMP, IT validation, and test...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab 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 IT compliance of our GenDocs system and associated business processes.The ideal candidate will have extensive knowledge of GxP systems, GAMP, IT validation, and test...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a 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 IT compliance of our GenDocs system and associated business processes.The ideal candidate will have a strong background in IT compliance, GxP systems, and Veeva Vault...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab 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.Key ResponsibilitiesMaintain...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab 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 IT compliance of our enterprise electronic document management system (EDMS), GenDocs, which supports daily operations in our dynamic and expanding R&D organization.Key...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing innovative products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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 RoleWe're seeking a System Compliance Manager to join our Digital Systems Management team, responsible for the clinical...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe...
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