System Compliance Manager
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 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.
- Passionate about Genmab's purpose and mission to transform the lives of patients through innovative cancer treatment.
- Bring rigor and excellence to all work, believing in Genmab's rooted-in-science approach to problem-solving.
- Generous collaborator who can work in teams with diverse backgrounds.
- Determined to do and be the best, taking pride in enabling the best work of others on the team.
- Not afraid to grapple with the unknown and be innovative.
- Experience working in a fast-growing, dynamic company, or a strong desire to.
- Work hard and have a little fun while doing so.
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