Compliance Manager for Electronic Document Management
3 weeks ago
At Genmab, we strive to create extraordinary futures by developing innovative antibody products and pioneering therapies that transform the lives of patients and change the future of cancer treatment and serious diseases. Our commitment to being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose, which is built on being caring, candid, and impact-driven. We believe in the importance of innovation and being rooted in science, and our unique business model supports our mission to excel and meet the expectations of our patients and stakeholders.
The Role
We are looking for an additional Compliance Manager to join our Digital Systems Management team, focusing on the GenDocs electronic document management system, which supports daily operations in our dynamic and expanding R&D organization. The successful candidate will be responsible for improving and developing the IT compliance of the GenDocs system and the associated business and administration processes around the system.
Key Responsibilities
- Develop and maintain comprehensive system compliance documentation, including validation master plans, risk registers, and system operation SOPs.
- Lead and conduct periodic review and other compliance activities, including critical user reviews, audit trail reviews, and annual system reviews.
- Oversee vendor compliance documents and ensure that compliance requirements are implemented and met.
- Liaise with QA, Legal, IT, and other Genmab departments to ensure that compliance requirements are met and implemented.
- Develop and optimize system processes for the operation and maintenance of the GenDocs system.
- Participate in future Veeva Vault projects as Validation Lead/SME, writing validation project documents, managing, and coordinating test activities.
- Develop and optimize IT validation procedures and tools in the team.
- Participate in system configuration or issue-related system administration work in the team.
- Prepare, coordinate, and participate in audits and inspections of the GenDocs system.
Requirements
- We expect the successful candidate to have a bachelor's degree in a relevant field, such as Life Science, IT, Engineering, or similar.
- At least 5 years of work experience in the pharmaceutical or biotech industry, with 1-2 years of experience in a similar role.
- Extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management.
- Participation in IT GxP projects, either 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.
About You
- You are passionate about our 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 you 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 do so.
- You work hard and are not afraid to have a little fun while you do so.
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleAt Genmab, we are seeking a System Compliance Manager to join our Digital Systems Management team. As a System Compliance Manager, you will play a pivotal role in ensuring the IT compliance of our electronic document management system, GenDocs, which is based on the Veeva Vault cloud platform. This system supports daily operations in our R&D...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody 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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.The RoleWe're seeking a System Compliance Manager to join our Digital Systems Management team, responsible for the clinical...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Description:System Manager for GenDocs and Regulatory AffairsAt Genmab, we are committed to developing innovative cancer treatments and pioneering therapies that change the lives of patients. As a System Manager, you will play a critical role in maintaining, developing, and operating our enterprise electronic document management system (EDMS), GenDocs,...
-
Compliance Manager for Digital Systems
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleAt Genmab, we are committed to developing innovative cancer treatments and transforming the lives of patients. We are seeking a highly skilled Compliance Manager to join our Digital Systems Management team. As a System Compliance Manager, you will be responsible for ensuring the IT compliance of our enterprise electronic document management...
-
Enterprise Electronic Document Management System
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title:System Manager, Regulatory Systems Management, Veeva RIMAbout the Role:At Genmab, we're committed to building an innovative future for our patients by developing groundbreaking antibody products and pioneering therapies for cancer treatment. We're seeking a skilled System Manager to join our Digital Systems Management team and contribute to the...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt 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) –...
-
System Compliance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleAt Genmab, we are seeking a skilled System Compliance Manager to join our Digital Systems Management team. The successful candidate will be responsible for ensuring the compliance of our enterprise electronic document management system, GenDocs, which supports daily operations in our dynamic and expanding R&D organization.The ideal candidate...
-
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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout This RoleGenmab is seeking a System Compliance Manager to join our Digital Systems Management team. As a key member of this team, you will be responsible for ensuring the compliance of our enterprise electronic document management system, GenDocs, with regulatory requirements and industry standards.Key ResponsibilitiesCompliance DocumentationPeriodic...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a Senior Compliance Expert to join our Digital Systems Management team at Genmab. As a key member of our team, you will play a vital role in ensuring the IT compliance of our electronic document management system (EDMS) – GenDocs.GenDocs is a global IT system based on the Veeva Vault cloud platform, supporting daily operations...
-
System Compliance Manager
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout GenmabWe're a biotech company committed to developing innovative cancer treatment and serious disease therapies. Our mission is to build extraordinary futures by pioneering therapies that change lives.The RoleWe're looking for a skilled System Compliance Manager to join our Digital Systems Management team. This team supports and develops IT systems,...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled IT Compliance Specialist to join our Digital Systems Management team at Genmab. As a System Compliance Manager, you will be responsible for ensuring the compliance of our enterprise electronic document management system (EDMS) with regulatory requirements.Key ResponsibilitiesMaintain system compliance...
-
Enterprise IT Compliance Specialist, Genmab R&D
24 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is a biotech company dedicated to transforming the lives of patients through innovative cancer treatment. We're seeking an experienced Enterprise IT Compliance Specialist to join our team.About the RoleThis is a unique opportunity to work in a fast-growing, dynamic company and make a significant impact on the development and operation of our...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled System Compliance Manager to join their Digital Systems Management team. The successful candidate will be responsible for ensuring the IT compliance of the GenDocs system and associated business processes. This will involve updating system documentation, conducting periodic reviews, and investigating issues or...
-
Datacenter Program Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Microsoft Full timeOverviewAt Microsoft, we're committed to creating an inclusive work environment where everyone can thrive. As a Datacenter Program Manager - Compliance, you'll play a critical role in ensuring our cloud services meet the highest standards of compliance and security.As a member of our Cloud Operations & Innovation team, you'll work closely with...
-
Digital Systems Compliance Specialist
5 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking an experienced System Compliance Manager to join our Digital Systems Management team at Genmab. As a key member of this team, you will be responsible for ensuring the compliance and regulatory requirements of our enterprise electronic document management system (EDMS) – GenDocs.GenDocs is a global IT system based on the Veeva...
-
Digital Systems Compliance Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are seeking a Digital Systems Compliance Specialist to join our team at Genmab, a global biotech company dedicated to developing innovative cancer treatments.About the RoleThe successful candidate will be responsible for maintaining system compliance documentation for our enterprise electronic document management system (EDMS), GenDocs. This involves...
-
Finance Manager
1 month ago
Copenhagen, Copenhagen, Denmark Folkekirkens Nødhjælp Full timeAbout the RoleThe Finance Manager will be responsible for the management and coordination of all accounting and finance related tasks within the DCA Syria Programme. This includes managing all budgetary activities, establishing and improving financial systems and processes, and training and capacity building of DCA and Partner staff.Key...
-
Ethics and Compliance Investigations Manager
3 days ago
Copenhagen, Copenhagen, Denmark Carlsberg Danmark Full timeJob OverviewWe are seeking an experienced Ethics and Compliance Investigations Manager to join our team at Carlsberg Danmark.About the RoleThis is a dynamic opportunity for a skilled professional to lead investigations into alleged ethics and compliance policy violations, ensuring the integrity of our business operations. As an Ethics and Compliance...
