IT Compliance Lead with exp in GxP and Pharma preferred

1 week ago


Copenhagen, Copenhagen, Denmark Ubique Systems Full time
IT Compliance Lead with exp in GxP and Pharma preferred

The IT Compliance Lead is responsible for defining and executing Validation and qualification strategy for the development and implementation of Genetics Analysis Platform, a Non-GxP SaaS solution, and subsequently another upcoming solution.

The IT Validation and Compliance Partner is responsible for delivering and writing end-to-end documentation. The role is also responsible for performing various assessments such as Supplier assessment, IT risk assessment, IT requirements risk assessment, functional and data integrity assessments.

The role is responsible for ensuring that the systems are in compliance with relevant internal and external regulatory requirements. The role will also participate in audits and inspections including finding solutions to compliance gaps identified in audits and inspections.

Seniority level
  • Mid-Senior level
Employment type
  • Contract
Job function
  • Consulting
  • Information Technology
  • Design
Industries
  • IT Services and IT Consulting
  • IT System Data Services
  • IT System Custom Software Development
#J-18808-Ljbffr

  • Copenhagen, Copenhagen, Denmark Ubique Systems Full time

    The Ubique Systems' IT Compliance Lead will play a critical role in ensuring the Genetics Analysis Platform meets regulatory requirements. This involves developing and executing a validation strategy for the Non-GxP SaaS solution.Responsibilities include creating end-to-end documentation, performing assessments, and writing technical reports. The role...


  • Copenhagen, Copenhagen, Denmark Ubique Systems Full time

    The Ubique Systems' IT Compliance Lead will define and execute a validation strategy for the development and implementation of a Non-GxP SaaS solution, Genetics Analysis Platform. The role is responsible for ensuring that systems are in compliance with internal and external regulatory requirements.Key responsibilities include delivering end-to-end...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    Senior Computerized Laboratory Equipment Consultant for GxP Implementation and ValidationTo support our growing customer portfolio in our QC laboratory domain, Pharma IT is searching for an experienced Computerized Laboratory Equipment Consultant for GxP Implementation and Validation to join our Laboratory IT consulting team.Pharma IT's Laboratory IT team...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    We are searching for a skilled GxP Compliance Expert to join our team. As a key member of our Laboratory IT consulting team, you will work closely with our clients to implement complex scientific laboratory equipment in pharmaceutical QC laboratories.Your primary responsibility will be to work independently or in collaboration with other team members to...


  • Copenhagen, Copenhagen, Denmark Ubique Systems Full time

    The Ubique Systems' IT Compliance Lead plays a crucial role in ensuring the Genetics Analysis Platform meets regulatory requirements. The platform is a Non-GxP SaaS solution, and the IT Compliance Lead will develop and execute a validation strategy.Responsibilities include creating end-to-end documentation, performing assessments, and writing reports. The...


  • Copenhagen, Copenhagen, Denmark Fusion Cons Full time

    Job RequirementsWe are seeking a highly skilled Senior Infrastructure Architect to support industrial automation and IT systems in GxP-regulated environments.The successful candidate will have a strong understanding of compliance, architecture frameworks, and manufacturing IT layers, particularly in relation to the Purdue Model.This role requires immediate...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    We are looking for a highly skilled GxP Regulatory Compliance Specialist to join our team at Genmab A/S. In this role, you will be responsible for ensuring that our quality management systems and testing processes comply with relevant regulatory requirements.About the RoleYou will work closely with cross-functional teams to develop and implement quality...


  • Copenhagen, Copenhagen, Denmark LEO Pharma Full time

    Company OverviewLEO Pharma is a global leader in medical dermatology, dedicated to leaving a lasting impact on patients, colleagues, and the planet. Our innovative approach sets us apart, empowering individuals to drive change and make a visible impact.We value diversity and welcome applications from all qualified candidates, recognizing that our different...


  • Copenhagen, Copenhagen, Denmark Eupry Full time

    We are seeking a highly experienced GxP Industry Specialist to join our Quality Team at Eupry. In this role, you will play a critical role in maintaining and improving our Quality Management System (QMS) to ensure compliance with industry regulations.Key Responsibilities:Lead efforts to develop and implement policies and procedures to ensure compliance with...


  • Copenhagen, Copenhagen, Denmark Ubique Systems Full time

    As a key member of the Ubique Systems' team, the IT Compliance Lead will be responsible for defining and executing a validation strategy for the Genetics Analysis Platform. This Non-GxP SaaS solution requires close attention to ensure compliance with internal and external regulatory requirements.The role involves delivering end-to-end documentation,...


  • Copenhagen, Copenhagen, Denmark LEO Pharma Full time

    About the RoleThe Head of Audits & Global Development Quality will be responsible for leading a team of auditors and quality professionals, ensuring compliance with regulatory requirements, and contributing to the development of the company's quality strategy.This is an exciting opportunity for an experienced professional to join LEO Pharma's Corporate...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    Job DescriptionWe are seeking a Senior Clinical Project Management Consultant to join our team at Pharma IT.The ideal candidate will have experience in leading clinical projects from initiation to closure, ensuring adherence to project timelines, budget, and scope.Responsibilities include developing comprehensive project plans, collaborating with...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    Principal Project Development Lead Job DescriptionWe are looking for a Principal Project Development Lead to join our Clinical Science & Trial Operations Team. As a consultant to our clients, you will develop and execute clinical projects from initiation to closure, ensuring adherence to project timelines, budget, and scope.You will be responsible for...


  • Copenhagen, Copenhagen, Denmark LEO Pharma Full time

    Job DescriptionKey Responsibilities:Lead and manage a team of global GxP auditors across LEO Pharma, both internally and externally.Oversee the Global Development Quality team working across LEO Pharma, both internally and externally.Ensure compliance with relevant legislation (GCP, GVP, RA) and maintain the highest standards of quality support for Global...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is an international biotechnology company committed to developing innovative antibody therapeutics that transform patient care. We are dedicated to creating next-generation antibody technology platforms and leveraging translational research and data sciences to push the boundaries of what is possible.About Our MissionWe strive to make a meaningful...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    About the RoleAs a Principal Medical Writer Specialist, you will be responsible for leading medical writing projects and collaborating with cross-functional teams to ensure successful outcomes.You will work closely with clients to understand their needs and provide expert-level medical writing services, including clinical document preparation and review.Our...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    At Pharma IT, we are seeking an experienced Senior Computerized Laboratory Equipment Consultant to join our growing team. As a key member of our Laboratory IT consulting team, you will work closely with our clients to implement complex scientific laboratory equipment in pharmaceutical QC laboratories.Your primary responsibility will be to work independently...


  • Copenhagen, Copenhagen, Denmark Impero - Compliance. Simplified. Full time

    Impero - Compliance. Simplified. is a leading SaaS company that streamlines financial and tax compliance for businesses worldwide.About the RoleWe are seeking a highly skilled Compliance Solutions Manager to join our Commercial Team. This pivotal role supports Sales Executives from a pre-sales perspective, leveraging subject matter expertise in financial...


  • Copenhagen, Copenhagen, Denmark LEO Pharma Full time

    Select how often (in days) to receive an alert: Senior Corporate Counsel - R&D Legal & HQ Operations Field of work: Legal, Audit & Compliance Posting Date: 10 Mar 2025 Shape the LEO Pharma of tomorrow At LEO Pharma, our mission goes beyond the ordinary. We're on an ambitious journey to become global leaders in medical dermatology.To support this mission we...


  • Copenhagen, Copenhagen, Denmark Impero - Compliance. Simplified. Full time

    Impero - Compliance. Simplified. is a fast-growing SaaS scale-up that simplifies financial and tax compliance for businesses worldwide.About the RoleWe are seeking a highly skilled Compliance Solutions Manager to join our Commercial Team. This pivotal role supports Sales Executives from a pre-sales perspective, leveraging subject matter expertise in...