System Compliance Manager, Digital Systems Management, Veeva Vaults
2 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 IT compliance of our enterprise electronic document management system (EDMS), GenDocs, which supports daily operations in our dynamic and expanding R&D organization.
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.
- Oversee vendor compliance documents and liaise with QA, Legal, IT, and other Genmab departments to ensure implementation of compliance requirements.
- Develop and optimize system processes for the operation and maintenance of GenDocs.
- Participate in future Veeva Vault projects as Validation Lead/SME and develop and optimize IT validation procedures and tools.
- Prepare, coordinate, and participate in audits and inspections of the GenDocs system.
- 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 and understanding of GxP systems, GAMP, IT validation, and test management.
- Participation in IT GxP projects, either as project SME or Validation Lead.
- Practical work experience with EDMS systems, preferably Veeva Vault administrator and platform certification.
- Excellent communication skills in English, written and oral.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We are committed to fostering workplace diversity and believe it is essential for our continued success.
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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 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 compliance of our electronic document management system (EDMS) - GenDocs, covering clinical development, regulatory affairs, CMC, and QA areas in R&D.The successful...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled System Manager to join our Digital Systems Management team. As a key member of our team, you will be responsible for maintaining, developing, and operating our enterprise electronic document management system (EDMS), GenDocs, which supports daily operations in our dynamic and expanding R&D organization.The...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled System Manager to join our Digital Systems Management team. As a key member of our team, you will be responsible for maintaining, developing, and operating our enterprise electronic document management system (EDMS), GenDocs, which supports daily operations in our dynamic and expanding R&D organization.The...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled System Manager to join our Digital Systems Management team. As a key member of our team, you will be responsible for maintaining, developing, and operating our enterprise electronic document management system (EDMS), GenDocs, covering clinical development, regulatory affairs, CMC, and QA areas in R&D.GenDocs...
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled System Manager to join our Digital Systems Management team. As a key member of our team, you will be responsible for maintaining, developing, and operating 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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