Genmab · 3 days ago
Risk Based Quality Management (RBQM) Specialist
Princeton, NJ
Full-time
Onsite
Director/Executive
$148K/yr - $222K/yr
8+ years expGenmab is an international biotechnology company dedicated to improving patient lives through innovative antibody therapeutics. They are seeking a Risk Based Quality Management (RBQM) Specialist to support clinical trial teams in planning and executing RBQM deliverables, ensuring effective monitoring and risk management throughout clinical trials.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
Support CTTs in developing Risk Assessment and Mitigation Plans, identifying critical-to-quality factors, PQTLs, KRIs, thresholds, and monitoring tactics
Conduct centralized monitoring of KRIs, PQTLs, and data quality signals; escalate trends and partner with CTT to define mitigation actions
Review protocols to identify critical data/process risks and influence quality-by-design approaches
Collaborate with RBQM vendors to ensure implementation of the selected RBQM model and maintain strong oversight
Review and approve trial-specific RBQM documentation for alignment with frameworks and SOPs
Support development, refinement and use of RBQM tools, templates and study management plans
Contribute to cross-trial learning by documenting lessons learned and applying insights across programs
Train and support internal and external stakeholders in RBQM methodology
Maintain strong knowledge of ICH/GCP and Genmab SOPs
Serve as a superuser of RBQM technology and support its optimal use
Facilitate the adoption and understanding of RBQM
Support implementation of RBQM and continuous training to Genmab employees and vendors as applicable
Support the update and maintenance of critical data and process risk library
Lead alignment efforts and drive continuous improvements in RBQM strategy, processes, and systems
Represent RBQM in operational committees or cross-functional fora
Lead vendor qualification activities, including scope of work development and oversight strategies
Lead development of the critical data and process risk library and lead specialized RBQM digital innovation initiatives
Lead departmental working groups, cross-functional projects and contributions to SOP revisions
Qualification
Required
You have a minimum of bachelor's degree and 8-10 years of relevant experience from biotech or pharma companies
You have proven experience in planning and executing RBQM activities in collaboration with CTT
You have been guiding CTT in identification of critical data and processes, performing risk assessment and mitigation workshops, defining appropriate monitoring strategies, and developing monitoring plans
You have been performing centralized monitoring of KRIs to identify trends and communicate the surfacing signals to CTT
You have experience in collaboration with clinical CRO in relation to planning and overseeing monitoring strategies
You understand the processes within trial management or data management
You either have a good understanding of oncology or a strong willingness to learn about oncology enabling you to identify clinical data and processes
You thrive with planning and organizational tasks
You work in an analytical manner and can interpret and present data
You understand clinical development/trial conduct, including GCP, ICH E6 (R3), ICH E8 (R1)
You have good communication skills
You are comfortable solving problems and making decisions
You are detail oriented and have a quality mindset
You enjoy working with process development
Benefits
401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Company
Genmab
Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.
1001-5000 employees
H1B Sponsorship
Genmab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (10)
2023 (6)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$11.7BKey Investors
Morgan Stanley Senior FundingGlaxoSmithKlineIndex Ventures
2025-11-18Post Ipo Debt· $6B
2025-09-29Post Ipo Debt· $5.5B
2010-07-01Post Ipo Equity· $134M
Leadership Team
Anthony Pagano
Chief Financial Officer
Anthony Mancini
EVP & Chief Operating Officer
Recent News
2026-01-16
2026-01-11
Pharma Letter
2026-01-09
Company data provided by crunchbase