Genmab

Risk Based Quality Management Specialist

Genmab

full-time

Posted on:

Location Type: Remote

Location: Remote • New Jersey • 🇺🇸 United States

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Salary

💰 $148,320 - $222,480 per year

Job Level

SeniorLead

Tech Stack

Google Cloud Platform

About the role

  • 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.

Requirements

  • A minimum of bachelor’s degree and 8-10 years of relevant experience from biotech or pharma companies
  • Proven experience in planning and executing RBQM activities in collaboration with CTT
  • Experience in guiding CTT in identification of critical data and processes, performing risk assessment and mitigation workshops, defining appropriate monitoring strategies, and developing monitoring plans
  • Experience in collaboration with clinical CRO in relation to planning and overseeing monitoring strategies
  • Understanding of the processes within trial management or data management
  • Good understanding of oncology or a strong willingness to learn about oncology
  • Analytical mindset to interpret and present data
  • Understanding of clinical development/trial conduct, including GCP, ICH E6 (R3), ICH E8 (R1)
  • Good communication skills
  • Detail oriented and quality mindset
  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Risk AssessmentMitigation PlansData Quality SignalsRBQM MethodologyMonitoring StrategiesTrial ManagementData ManagementAnalytical SkillsProcess Development
Soft skills
CollaborationCommunicationDetail OrientedQuality MindsetTraining
Certifications
Bachelor's Degree