System Compliance Manager, Digital Systems Management, Veeva Vaults
4 weeks ago
At Genmab, we're dedicated to creating a brighter future for patients with innovative cancer treatments. Our team is passionate about developing antibody products that change lives. We're looking for a System Compliance Manager to join our Digital Systems Management team, which supports our enterprise electronic document management system (EDMS) – GenDocs.
The Role
As a System Compliance Manager, you'll be responsible for ensuring the GenDocs system meets regulatory requirements and industry standards. You'll work closely with our QA, Legal, and IT teams to implement compliance requirements and develop optimized system processes. Your expertise in GxP systems, GAMP, and IT validation will be invaluable in this role.
Responsibilities
- Develop and maintain system compliance documentation, including validation master plans and risk registers.
- Lead periodic reviews and other compliance activities, such as critical user reviews and audit trail reviews.
- Oversee vendor compliance documents and ensure implementation of compliance requirements.
- Liaise with QA, Legal, and IT teams to ensure compliance with industry standards.
- Develop and optimize system processes for the operation and maintenance of the GenDocs system.
- Participate in future Veeva Vault projects as Validation Lead/SME.
Requirements
- Bachelor's degree in Life Science, IT, Engineering, or a related field.
- At least 5 years of 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.
About Genmab
Genmab is a biotech company committed to developing innovative cancer treatments. We're a dynamic and expanding organization with a global presence. Our team is passionate about creating a brighter future for patients, and we're looking for like-minded individuals to join us.
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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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