Global Veeva Vault Quality Business Partner & Product Lead

At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workplace where individuals unique contributions are valued and drive innovative solutions to meet the needs of our patients care partners families and employees.

Our people are compassionate candid and purposeful and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes our work is incredibly serious and impactful but we have big ambitions bring a ton of care to pursuing them and have a lot of fun while doing so.

Does this inspire you and feel like a fit Then we would love to have you join us!

The Role

We are seeking a Veeva Vault Quality Business Partner & Product Lead to drive a robust compliant and user-friendly Quality system. You will bridge business and IT translate needs into scalable solutions promote system adoption ensure GxP compliance and unlocking the full value of Quality for business functions. As part of the Digital TechOps team you will collaborate across the broader Veeva ecosystem to deliver a seamless digital experience.

You will also have the opportunity to contribute to Genmabs bold vision: that by 2030 our knock-your-socks-off (KYSO) antibody medicines are transforming the lives of people with cancer and other serious diseasespowered by a global team using data digital and AI to revolutionize the way we work across the biotech value chain.

Responsibilities

Product ownership & roadmap

• Serve as a business representative for Vault Quality

• Define the product vision roadmap and quarterly priorities in collaboration with the system owner

• Prioritize a balanced backlog (compliance usability integrations automation) based on business impact and risk

• Maintain a transparent change pipeline and communicate releases benefits and impacts to stakeholders

Business liaison & requirements management

• Act as the day-to-day liaison between DD&AI and LoB to capture and consolidate requirements

• Translate business needs into clear URS and functional specs including workflows lifecycles security roles metadata and document types

• Facilitate design workshops and validate proposed solutions with process owners and SMEs

Configuration & administration (minor configuration)

• Perform light configuration on behalf of the business (metadata picklists document type templates lifecycle states security groups training assignments views/dashboards)
• Maintain business-owned templates (SOP WI Forms Specs) and controlled vocabularies/taxonomies
• Partner with DD&AI for complex configurations integrations and environment management

Validation release & change control (GxP)

• Lead business activities for computerized system validation in partnership with QA/IT: risk assessments UAT scripts execution and approval

• Ensure releases follow change control and impact assessment

• Build and run a super-user network across sites/ functions developing targeted training and driving system adoption

• Create targeted training (role-based quick guides micro-videos job aids) and deliver onboarding for new teams

• Drive adoption through measurements and targeted efforts

Operations & service delivery

• Oversee day-to-day Veeva Quality operations: eg access requests and effectiveness checks

Value maximization & continuous improvement

• Identify automation and simplification opportunities (templates auto-metadata training automation AI-assisted search)

• Lead key improvements end-to-endfrom problem statement and business case to deployment and benefit realization

• Benchmark and incorporate Veeva best practices and industry standards

Documentation & knowledge management

• Keep business documentation current: process maps SOPs/WIs configuration guides data dictionaries and training materials

• Curate a self-service knowledge hub and feedback channel for users and super-users

Requirements

• Bachelors or Masters degree in Life Sciences Engineering Quality or IT (Veeva/Agile certifications is a plus)

• 57 years of experience with Veeva Vault (ideally Veeva Quality) in a GxP life-sciences environment

• Proven ability to act as Product Owner/Business Partner for digital quality systems defining roadmaps and prioritizing backlogs

• Experience collaborating with QA Manufacturing Supply Chain and IT/Digital in matrixed global organizations

• Hands-on skills in Vault configuration (metadata lifecycles document types security roles vocabularies)

• Skilled in requirements gathering URS writing functional specs and facilitating cross-functional design workshops

• Ability to lead UAT perform impact assessments and support compliant release/change processes

• Track record identifying and delivering automation/simplification opportunities (templates metadata AI-assisted search)

• Strong communication and change management skills including training creation and driving user adoption

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can 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!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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