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!
About R&D Quality
R&D Quality encompasses four teams GCP Quality, GCLP/GLP Quality, PV Quality, and Audit Calibration. R&D Quality has a large range of stakeholders, and we have an important role in delivering our 2030 vision to transform the future of cancer treatment.
The Role
The (Senior) Project Manager leads the logistics of all the regulatory inspection within GCP, GVP and GLP including being responsible for ensuring that the Inspection Share Point Site and Hub are continuously enhanced and maintained Furthermore, the role includes responsibility for the audit risk documentation, documentation package for contract auditors, training documentation and data collection and slide deck presentations.
To optimize the efficiency of the above responsibilities the (Senior) Project Manager will design, develop and maintain digital solutions within the R&D Quality Space and through these solutions will ensure transparency of the documentation generated.
The role will include management and support of GxP documentation in a Veeva Vault system as user. Training can be provided if you do not have experience with the system
Key responsibilities (including but not limited to)
Coordinate the logistic, planning and communication activities related to GCP/GVP/GLP inspections and in collaboration with the Inspection QA Lead, Team Leads and Head of R&D Quality
Plan and schedule inspection meetings
Co-partnership with Inspection QA Lead to ensure agenda, presentations and follow up activities and commitments at meetings related to Inspections
Continued improvement and maintenance of a logistic plan for inspections hosted by any Genmab Office (DK & US) in the area of R&D Quality including rehearsals prior to inspections
Continued improvement and maintenance of the Inspection Share Point Site and Hub
Ensure planning and deliverables of IT equipment and catering in collaboration with the IT service management and local facility
Testing of inspection set up
Ensure inspection documentation is filed in a structured way
Develop and maintain digital solutions and tools to facility oversight of Role and Responsibilities at inspections in partnership with Inspection QA Lead
Support Inspection QA Lead as the actual inspections
Coordinate inspection presentation and their readiness when presented
Establish an inspection dashboard and report to the Head of R&D Quality
Support in data collection and data handling for audit risk assessment
Responsible for the audit risk assessment and plan documentation management and updates in collaboration with the PV Quality, GCP Quality, GCLP/GLP Quality, and Audit Calibration
Prepare documentation package for contract auditors and ensuring secure electronic sharing
Follow up on data entry and filing for contracted audits
Design digital solutions for training documentation and ensure applicable filing
Develop and maintain a digital solution to facilitate overview of audit qualifications within different areas of R&D Quality
Requirements
Bachelor degree required
5-8+ years of experience with proved project management experience/business analyst experience in a biotech or pharma industry
IT capabilities in SharePoint sites and digital solutions
Proven performance in similar role
The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:
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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.
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