Compliance Systems Manager, Digital Solutions

6 dagen geleden

Utrecht, Utrecht, Nederland Genmab Voltijd

About Genmab

At Genmab, we are dedicated to creating extraordinary futures by developing innovative antibody products and groundbreaking therapies that significantly impact the lives of patients and the future of cancer treatment and serious diseases. Our culture is built on the principles of care, transparency, and a commitment to making a difference, which we believe is essential to achieving our mission.

Position Overview

We are seeking a System Compliance Manager to join our enterprise electronic document management system (EDMS) team, focusing on GenDocs, which supports clinical development, regulatory affairs, CMC, and QA within our R&D sector. GenDocs operates on the Veeva Vault cloud platform, facilitating daily operations in our rapidly growing R&D organization.

The Digital Systems Management team, located globally in the US and Europe, is responsible for supporting, developing, and enhancing IT systems, primarily Veeva Vaults, and processes in R&D. Our collaborative approach allows us to understand and address the business needs of various departments to optimize system performance.

As a System Compliance Manager, your role will involve enhancing and developing the IT compliance of the GenDocs system along with the associated business and administrative processes. This will require close collaboration with team members, including updating system documentation, conducting regular reviews, addressing issues or new requirements, and improving processes for system operation and maintenance.

Key Responsibilities

  • Maintain compliance documentation throughout the operation of GenDocs (Validation Master Plan, Risk Register, system operation SOPs, etc.)
  • Lead and conduct periodic compliance activities, including critical user reviews and audit trail assessments
  • Oversee vendor compliance documentation and review compliance reports
  • Collaborate with QA, Legal, IT, and other departments to implement compliance requirements affecting the systems
  • Develop and enhance operational processes for the GenDocs system
  • Act as Validation Lead/SME in future Veeva Vault projects, including writing validation documents and managing test activities
  • Optimize IT validation procedures and tools within the team
  • Engage in system configuration and administration tasks as needed
  • Prepare for and participate in audits and inspections of the GenDocs system

Qualifications

  • Bachelor's degree in Life Science, IT, Engineering, or a related field
  • A minimum of 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
  • Experience in IT GxP projects as a project SME or Validation Lead
  • Practical experience with EDMS systems, preferably with Veeva Vault certification
  • Excellent communication skills in English, both written and verbal
  • Familiarity with IT testing tools, such as HP ALM or Jira, is a plus

Personal Attributes

  • Ability to work independently and collaboratively within a team
  • Service-oriented mindset with a positive attitude towards challenges
  • Pragmatic approach, able to appreciate different perspectives
  • Strong sense of responsibility and personal drive
  • Structured and systematic, adapting detail levels to context

About You

  • Passionate about our mission to transform patient lives through innovative cancer treatments
  • Committed to excellence and a science-based approach to problem-solving
  • A collaborative team player with diverse background experience
  • Determined to achieve personal and team success
  • Comfortable navigating uncertainty and fostering innovation
  • Experience in a dynamic, fast-paced environment is preferred
  • Hardworking with a sense of enjoyment in the work

Work Environment

Genmab promotes an agile working environment to enhance employee work-life balance. Our offices are designed as open, community-focused spaces that foster collaboration while being integrated with state-of-the-art laboratories. Whether working in our innovative office spaces or remotely, we prioritize connection and collaboration to drive innovation.

  • Compliance Systems Manager, Digital Solutions

    5 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About GenmabAt Genmab, we are dedicated to creating extraordinary futures by developing innovative antibody therapies that significantly impact the lives of patients battling cancer and other serious diseases. Our culture is built on the principles of care, transparency, and a commitment to making a difference through scientific innovation.Position...

  • Compliance Systems Manager, Digital Operations

    6 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About GenmabAt Genmab, we are dedicated to crafting extraordinary futures through the development of innovative antibody therapies that significantly impact patient lives and advance cancer treatment and other serious conditions. Our team is characterized by a culture of care, transparency, and a commitment to making a difference, underpinned by a strong...

  • Digital Systems Compliance Specialist

    5 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About GenmabAt Genmab, we are dedicated to creating extraordinary futures by developing innovative antibody products and groundbreaking therapies that transform the lives of patients facing cancer and serious diseases. Our team is characterized by a culture of care, transparency, and a commitment to making a significant impact. We believe that embracing...

  • Digital Systems Compliance Specialist

    5 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About GenmabAt Genmab, we are dedicated to creating extraordinary futures through the development of innovative antibody products and groundbreaking therapies that significantly impact patient lives and advance cancer treatment. Our team is characterized by a culture of care, transparency, and a focus on making a difference, driven by our commitment to...

  • Digital Systems Compliance Lead

    5 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About GenmabAt Genmab, we are dedicated to creating extraordinary futures by developing innovative antibody therapies that significantly impact the lives of patients and the landscape of cancer treatment and serious diseases. Our culture is built on the principles of care, transparency, and a drive for impact, with a strong foundation in scientific...

  • Digital Transformation Specialist

    4 uur geleden

    Utrecht, Utrecht, Nederland T-Systems Netherlands Voltijd

    About the RoleWe are seeking a highly skilled Digital Transformation Specialist to join our team at T-Systems Netherlands. As a Digital Transformation Specialist, you will play a pivotal role in driving the adoption of digital solutions across various industries, including Manufacturing, Consumer Packaged Goods (CPG), and Public Services, including Transport...

  • Senior Software Engineer, Intelligent Automation, R&D Digital Solutions

    6 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleGenmab is seeking a highly skilled Senior Software Engineer to join our R&D Digital Solutions team. As a key member of our team, you will be responsible for designing, developing, and implementing automation solutions using Microsoft Power Platform and other cloud-based technologies.Key ResponsibilitiesDesign and develop automation solutions...

  • Digital Solutions Coordinator

    5 dagen geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    Job Summary: We are seeking a highly skilled IT Implementation Specialist to join our team at the HKU Faculty of Social Sciences. The successful candidate will be responsible for supporting the implementation and change management of digital solutions aimed at developing a carer-friendly community in collaboration with community partners.Key...

  • IT Solutions Manager

    5 dagen geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    Job SummaryThe HKU is seeking a highly skilled IT Solutions Manager to provide technology vision and leadership in the digital solution and implementation regarding solution architecture, data architecture, security, scalability, and performance.Key ResponsibilitiesDesign and implement security controls, data resilience, and data recovery measures.Manage the...

  • Senior Software Engineer, Intelligent Automation, R&D Digital Solutions Developer

    6 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a highly skilled Senior Software Engineer to join our Intelligent Automation team in R&D Digital Products. As a key member of our team, you will be responsible for designing, developing, and implementing automation solutions using Microsoft Power Platform and other cloud-based platforms.Key ResponsibilitiesDesign and develop...

  • Senior Software Engineer, Digital Innovation, R&D Automation

    5 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleGenmab is seeking a highly skilled Senior Software Engineer to join our R&D Digital Team. As a key member of our team, you will be responsible for designing, developing, and implementing automation solutions using Microsoft Power Platform and other cutting-edge technologies.Key ResponsibilitiesDesign and develop automation solutions tailored...

  • IT Systems Development Manager

    5 dagen geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    Job SummaryThe HKU is seeking a highly skilled IT Systems Development Manager to join our team. As an IT Systems Development Manager, you will be responsible for designing, building, and enhancing software systems based on business requirements.Key ResponsibilitiesDesign and develop software systems using agile approach, microservices, DevOps, API, and App...

  • Solution Architect

    2 maanden geleden

    Utrecht, Utrecht, Nederland De Rijksoverheid Voltijd

    Geef vorm aan de IT-architectuur van de rechtspraak in ons land. En leg zo de basis voor een vlotte en veilige digitale afhandeling van rechtszaken, van a tot z. Jij ontwerpt mee aan het IT-landschap van de rechtspraak in Nederland. Want jij vertaalt de vragen van onze klanten naar technische oplossingen. Die klanten zijn rechters, griffiers, advocaten of...

  • IT Solution Manager Market To Order

    5 dagen geleden

    Utrecht, Utrecht, Nederland Good Company Voltijd € 12

    Ken de organisatieOnze opdrachtgever is een toonaangevend bedrijf in de zorgsector met vestigingen in heel Europa. Zorg zit in het hart van dit bedrijf en in het DNA van de medewerkers. Ze zetten klanten centraal bij alles wat ze doen en streven er altijd naar een verschil te maken. Voor zowel zorgprofessionals en zorgverzekeraars als patiënten. Ze nemen...

  • System Signalling Engineer

    5 dagen geleden

    Utrecht, Utrecht, Nederland Alstom Voltijd

    About the RoleWe are seeking a highly skilled System Signalling Engineer to join our team at Alstom. As a key member of our engineering team, you will be responsible for designing and developing signalling systems for our railway projects.Key ResponsibilitiesDesign and develop signalling systems for railway projects, ensuring compliance with industry...

  • Computer Systems Validation

    2 maanden geleden

    Utrecht, Utrecht, Nederland Capgemini Voltijd

    Jouw baan als Computer Systems Validation (CSV) Engineer bij Capgemini EngineeringCapgemini Engineering zoekt een gedreven Computer Systems Validation (CSV) Engineer die verantwoordelijk zal zijn voor het testen en kwalificeren van procesinstallaties, apparatuur en gebouwen. Als CSV Engineer coördineer je zorgvuldig alle test- en kwalificatie/validatie...

  • Junior Compliance Specialist

    5 dagen geleden

    Utrecht, Utrecht, Nederland Yacht Voltijd

    BedrijfsomschrijvingBij Yacht staat jouw talent centraal, waarbij we geloven in de kracht van groei door diverse organisaties en functies te verkennen binnen de financiële dienstverlening. Bij ons ben je verzekerd van contractuele zekerheid en ondersteunen we je bij elke stap in je carrière. We voeren voortdurend gesprekken met jou om je achtergrond,...

  • Solution Architect

    2 maanden geleden

    Utrecht, Provincie Utrecht, Provincie Utrecht, Nederland Independent Recruiters Voltijd

    Ben jij een ervaren Solution Architect met een scherp oog voor bedrijfsprocessen in een complexe IT omgeving? Vind je het leuk om complexe digitale vraagstukken te vertalen naar heldere en effectieve oplossingen voor het software engineering team? Dit is niet de typische rol van Solution Ar

  • Project Manager

    5 dagen geleden

    Utrecht, Utrecht, Nederland Yacht Voltijd

    About YachtYacht is a leading provider of compliance and risk management solutions, with a strong network of professionals and a reputation for excellence in the industry.Job DescriptionJob Title: Project Manager - Sanctions ExpertJob Summary: We are seeking an experienced Project Manager to join our team as a Sanctions Expert. The successful candidate will...

  • Client Solutions Manager

    5 dagen geleden

    Utrecht, Utrecht, Nederland Oracle Voltijd

    About the RoleWe are seeking a highly skilled and experienced Client Solutions Manager to join our team at Oracle. As a key member of our sales team, you will be responsible for identifying and pursuing new business opportunities, as well as managing existing client relationships to drive revenue growth and margin expansion.Key ResponsibilitiesProactively...