System Compliance Manager, Digital Systems Management, Veeva Vaults
1 month 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 enterprise electronic document management system (EDMS), GenDocs, with regulatory requirements and industry standards.
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 Life Science, IT, Engineering, or a related field.
- 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.
- Participated in IT GxP projects 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 committed to improving the lives of patients through innovative and differentiated antibody therapeutics. Our team is passionate, innovative, and collaborative, and we strive to create a workplace that is inclusive and diverse.
We are committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application.
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