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System Compliance Manager, Digital Systems Management, Veeva Vaults
4 weeks ago
Genmab 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 administration. You will work closely with our team to develop and optimize system processes, conduct periodic reviews, and participate in future Veeva Vault projects.
Key Responsibilities- Maintain system compliance documentation, including validation master plans and risk registers.
- Lead and conduct periodic reviews and other compliance activities, such as critical user reviews and audit trail reviews.
- 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 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.
- Practical experience with EDMS systems and Veeva Vault administration.
- Excellent communication skills in English, written and oral.
- You are passionate about Genmab's mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do, with a strong focus on problem-solving.
- You are a collaborative team player with diverse backgrounds.
- You are determined to do and be your best, with a strong sense of pride in your work.
