Senior Manager, Quality Global Affiliates

At Genmab, we are dedicated to building extra[not]ordinary® 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 The Senior Manager, Quality Global Affiliates Excellence, develops and owns selected shared Quality processes that enable Genmab’s affiliates to operate compliantly and efficiently as the business expands. The role simplifies ways of working, reduces duplication and affiliate workload, and builds scalable solutions that can be deployed across existing and new markets. Working closely with affiliate Quality leads, global process owners and cross-functional partners, the role combines process ownership with hands-on implementation. A key responsibility is ownership of the affiliate training framework, including shared curricula, governance and ongoing maintenance. The scope of other process ownership is agreed with the Head of Quality Global Affiliates and relevant global process owners, with clear interfaces to local responsibilities. The role serves as a key connection point between Global Quality and affiliate Quality organizations, coordinating implementation activities, promoting standardization, and enabling the exchange of best practices and lessons learned across markets. Responsibilities Affiliate QMS and launch readiness

• Support new affiliate establishment, onboarding of local Quality leads and Responsible Persons, and implementation of the global Quality Management System. Work with local experts to identify and address additional local requirements
• Coordinate Quality readiness activities for market entry and commercial launches, tracking dependencies, milestones and risks and escalating issues requiring decisions or additional resources
• Support inspection readiness through shared tools, knowledge exchange and follow-up on recurring findings and improvement opportunities

Process ownership and scalable ways of working

• Own the design, implementation, maintenance and continuous improvement of assigned affiliate processes, including procedures, tools, governance, performance measures and user support
• Review affiliate workflows with local Quality leads to identify duplication, unnecessary complexity and activities that can be managed centrally or through shared services. Prioritise improvements based on compliance risk, affiliate effort and business needs
• Move agreed repeatable activities into shared solutions with clear responsibilities, handovers and support arrangements, reducing the need for each affiliate to develop and maintain its own approach
• Partner with global process owners to make global Quality processes practical for affiliates. Establish a common core with justified local adaptations, preserving local Quality oversight and statutory responsibilities

Affiliate training framework

• Own and maintain the affiliate training framework in partnership with Global Training, including role and task curricula, assignment principles, onboarding pathways and change governance
• Lead the affiliate training coordinator network and coordinate consistent implementation across markets. Maintain shared training matrices and coordinate updates following changes to global procedures
• Establish efficient arrangements for training assignment, administration and reporting with Global Training and affiliate coordinators. Retain clear local responsibility for identifying local requirements and confirming role applicability

Monitor training completion and effectiveness, address recurring gaps with relevant stakeholders, and simplify training requirements and administration where justified - Quality oversight and continuous improvement

• Streamline affiliate Quality Management Reviews through common inputs, reporting and follow-up tools, and facilitate Quality Risk Management activities across affiliates
• Use process performance, affiliate feedback, inspection findings and workload data to identify improvements. Measure benefits through reduced duplication and effort, timely implementation and sustained process effectiveness
• Partner with relevant system owners to introduce proportionate digitalisation and automation

Project delivery and capability building

• Lead cross-functional improvement projects from problem definition through implementation and benefit evaluation, managing priorities and dependencies across multiple affiliates
• Build stakeholder commitment, provide practical guidance and training, and follow through on adoption so that improvements become part of everyday work
• Capture and share best practices and lessons learned through reusable guidance, peer networks and onboarding materials, strengthening the capabilities of small affiliate Quality teams

Requirements

• Master’s degree in pharmacy, life sciences, engineering or a related scientific discipline
• Approximately 7–10 years of relevant Quality experience within the pharmaceutical or biotechnology industry
• Strong understanding of Good Distribution Practice and other GxP requirements relevant to affiliate operations, with experience implementing or improving Quality Management Systems
• Demonstrated experience owning or substantially improving processes across multiple markets or functions, with measurable gains in simplicity, efficiency or effectiveness
• Experience with Quality Risk Management and inspection readiness, including the ability to coordinate these activities across multiple markets
• Experience developing and implementing Quality guidance, tools, and training to enable structured, consistent, and scalable ways of working across affiliates
• Strong analytical, problem-solving, and process-improvement capabilities, with the ability to identify trends, simplify processes, and drive harmonization across markets with differing regulatory requirements
• Strong stakeholder management, communication, and influencing skills, with the ability to collaborate effectively across global and local organizations and drive outcomes without direct authority

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK666.400,00-999.600,00 The final salary offer will depend on several factors, including your skills, qualifications, and experience. In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process. 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, Genmab’s 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 Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).