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System Compliance Manager
2 months 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 GenDocs system and associated business processes.
The ideal 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 compliance requirements are met, and develop and optimize system processes for the operation and maintenance of GenDocs.
Responsibilities- Maintain system compliance documentation, including Validation Master Plans, Risk Registers, and SOPs.
- Lead and conduct 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.
- Develop and optimize system processes for the operation and maintenance of GenDocs.
- Participate in future Veeva Vault projects as Validation Lead/SME.
- Develop and optimize IT validation procedures and tools.
- Participate in system configuration and issue-related system administration work.
- Prepare and coordinate audits and inspections of the GenDocs system.
- 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.
- Participated in IT GxP projects as project SME or Validation Lead.
- Practical experience with EDMS systems, preferably Veeva Vault administrator and platform certification.
- Excellent communication skills in English, written and oral.
- You are passionate about Genmab's purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do, and are a fierce believer in our rooted-in-science approach to problem-solving.
- You are a generous collaborator who can work in teams with diverse backgrounds.
- You are determined to do and be your best, and take pride in enabling the best work of others on the team.
- You are not afraid to grapple with the unknown and be innovative.
- You have experience working in a fast-growing, dynamic company, or a strong desire to.
- You work hard and are not afraid to have a little fun while you do so.
