Risk-Based Quality Management (RBQM) Specialist
Company: Genmab
Job ID: R15031
Category: Development Operations
Locations: Multiple locations (Global)
Work Model: Hybrid / Onsite (location-dependent)
Career Level: Senior Manager or Associate Director (based on experience)
Job Overview
Genmab is expanding its Risk-Based Quality Management (RBQM) capabilities and is seeking a highly experienced RBQM Specialist to support the design, monitoring, and delivery of global clinical trials. This role will be instrumental in embedding quality-by-design principles and ensuring proactive risk identification, monitoring, and mitigation across clinical development programs.
The RBQM Specialist will partner closely with Clinical Trial Teams (CTTs), data management, vendors, and CROs to ensure RBQM deliverables are executed efficiently and in compliance with global regulations and Genmab SOPs. Candidates with advanced RBQM expertise may also contribute to strategic, cross-trial harmonization and functional leadership initiatives.
Key Responsibilities
Support Clinical Trial Teams in developing Risk Assessment and Mitigation Plans (RAMPs)
Identify critical-to-quality (CtQ) factors, PQTLs, KRIs, thresholds, and monitoring strategies
Perform centralized monitoring of KRIs, PQTLs, and data quality signals; identify trends and escalate risks
Review clinical protocols to identify critical data and process risks and influence quality-by-design approaches
Collaborate with RBQM vendors to ensure correct implementation and oversight of selected RBQM models
Review and approve trial-specific RBQM documentation in alignment with SOPs and RBQM frameworks
Support development and continuous improvement of RBQM tools, templates, and study management plans
Document lessons learned and contribute to cross-trial knowledge sharing
Train internal teams, vendors, and external stakeholders on RBQM methodologies
Maintain strong working knowledge of ICH-GCP, ICH E6 (R3), ICH E8 (R1), and Genmab procedures
Act as a superuser for RBQM technologies and support optimal system utilization
Support maintenance and enhancement of the critical data and process risk library
Advanced / Leadership Responsibilities (Based on Seniority)
Lead RBQM strategy alignment and continuous process improvement initiatives
Represent RBQM in cross-functional governance forums and operational committees
Lead RBQM vendor qualification, scope definition, and oversight strategies
Drive digital innovation initiatives related to RBQM analytics and systems
Lead cross-functional working groups and contribute to SOP development and updates
Required Qualifications & Experience
Bachelor’s degree or higher in a scientific discipline
8–10 years of relevant experience within biotech or pharmaceutical organizations
Demonstrated experience planning and executing RBQM activities in collaboration with Clinical Trial Teams
Hands-on experience conducting risk assessment workshops and defining monitoring strategies
Proven experience performing centralized monitoring of KRIs and interpreting data trends
Experience collaborating with CROs on monitoring strategy development and oversight
Strong understanding of clinical trial management and/or data management processes
Oncology experience or strong willingness to develop oncology expertise
Strong analytical, organizational, and problem-solving skills
Ability to interpret, present, and communicate complex data effectively
Solid understanding of global clinical development regulations and guidelines
High attention to detail with a strong quality and compliance mindset
Compensation (United States)
Salary Range: USD 148,320 – 222,480 annually
Final compensation will be based on qualifications, experience, role level, and geographic location. Additional incentives may include performance-based bonuses and long-term compensation programs.
Employee Benefits (US-Based Roles)
401(k) plan with company match
Comprehensive medical, dental, and vision insurance options
Paid vacation, sick leave, holidays, and paid parental leave
Wellness and lifestyle spending benefits
Tuition reimbursement and commuter benefits
Family care, financial wellness, and emotional well-being support programs
About Genmab
Genmab is a global biotechnology company focused on developing innovative and differentiated antibody therapeutics for cancer and serious diseases. With more than 25 years of scientific leadership, Genmab leverages advanced antibody technologies, translational science, and data-driven innovation to deliver life-changing therapies worldwide. Headquartered in Copenhagen, Denmark, Genmab operates across North America, Europe, and Asia-Pacific.
Why Join Genmab
Shape modern, risk-based approaches to clinical trial delivery
Work at the forefront of RBQM innovation and digital transformation
Collaborate with global clinical development and quality experts
Make a meaningful impact on patient safety and trial quality
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