Risk Based Quality Management (RBQM) Specialist

Genmab

1d

About The Position

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 Genmab is expanding its Risk Based Quality Management (RBQM) capabilities and is seeking an experienced and motivated RBQM Specialist to play a key role in shaping how we design, monitor and deliver our clinical trials. You will join the RBQM team and support the Clinical Trial Teams (CTTs) in timely planning and execution of RBQM deliverables in accordance with standard operating procedures and practices from study start-up through trial closure. You will drive the development of Risk Assessment and Mitigation Plan, identification of critical to quality factors, Parameters with Quality Tolerance Limits (PQTLs), Key Risk Indicators (KRIs), thresholds for action and monitoring tactics, as well as identification of de-risking initiatives and mitigation activities. You will closely collaborate with relevant vendors to ensure proper implementation of applicable RBQM model selected for the study according to the agreed roles and responsibilities. Candidates with broader strategic or leadership experience may additionally contribute to cross-trial harmonization, RBQM innovation and functional leadership initiatives.

Requirements

• For this role we need you, who have previous experience in working with RBQM adoption, including identification of critical data and process, associated risks and monitoring strategies.
• You will have a key role in bringing together all the relevant skill areas involved in monitoring activities.
• You are motivated to work in a company culture with an entrepreneurial spirit along with highly competent colleagues.
• You thrive in a changing environment where you have great opportunities to influence the path and outcome.
• 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

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees