IT System Administrator

Genmab; København; On-site; DKK 597,000 - 896,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab is expanding its QC IT systems and seeks an IT System Administrator to join onsite in Ballerup. You will provide administrative and developmental support to QC IT systems, primarily Labvantage LIMS and Empower software, ensuring regulatory compliance and system validation.

You will own validation packages, SOPs and training, collaborate with QA and application managers, manage user access, and help shape the way we work with laboratory IT to support cGMP in a fast-paced, pioneering

Qualifications

• At least 5 years of professional experience working according to GMP in a QC setting.
• Strong understanding of software validation requirements and current trends.
• Experience in qualification of analytical instruments is desirable.
• Experience in leading projects and driving cross-functional initiatives/stakeholders.

Responsibilities

• Liaise between System Users, Application Managers (IT) & QA.
• Drive business aspects of system application operations, design, testing, and improvements.
• Manage user access administration and provide initial and ongoing training for users.
• Maintain validated state of GxP systems and ensure data integrity and compliance with SOPs and cGMP.

Skills

GMP experience

Software validation

Project leadership

Cross-functional collaboration

Tools

LIMS (Labvantage)

Empower

QC systems

Job description

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 and Department

Our QC lab is growing in activities and looking to recruit an IT System Administrator to join our team onsite in Ballerup.

As IT system administrator at Genmab, you will provide administrative and developmental support to all our QC IT systems in our Quality Control Laboratory.

The laboratory is responsible for supporting Genmab’s innovative products by performing release and stability testing according to ICH guidelines. Systems are mainly the Labvantage Laboratory Information Management System (LIMS), but also the Empower Chromatography software and additional software controlling analytical equipment.

The role requires a detailed understanding of the LIMS and Empower systems used by QC and its maintenance requirements. The IT system administrator will own the system validation packages, the SOPs, and associated training packages.

The position requires compliance with regulatory requirements to cGMP. Unique to this position is the chance to define the way we work with laboratory IT systems at Genmab.

You will be joining a small team of ambitious and professional colleagues within related fields, who can help you settle into your role, and keep the spirit high while performing the important tasks for our laboratory. The laboratory is newly established, so expect a pioneering atmosphere, where you will help adjust the ways of working in an efficiency oriented direction. We expect you to be ambitious, motivated, self-driven, and to be able to make your colleagues shine in an environment of respectful and flexible collaboration.

You will report to the Associate Director of QC Support, Laboratory systems and Equipment.

Responsibilities

• Liaison between System Users, Application Managers (IT) & QA.
• Drives Business related aspects of system application operations, design, testing, and improvements.
• Manage user access administration and providing initial and on-going training for users.
• Responsible for practical aspects of maintaining the validated state of GxP systems.
• Ensure data integrity and compliance with company SOPs, requirement specifications, and cGMP regulations.
• Load and configure method templates in LIMS and Empower.
• Perform all aspects of QMS processes – Change Control, Deviations, CAPAs – for software used in QC lab.
• Report achievements and escape issues.

Requirements

• It is expected that you have at least 5 years of documented professional experience working according to GMP in a QC setting
• You have a thorough understanding of the detailed requirements for Software Validation and are up to date with current trends
• Experience with qualification of analytical instruments is desirable as you will be the owner of the validation and qualification activities
• Experience in leading projects and driving cross-functional initiatives/stakeholders

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

DKK597.312,00---895.968,00

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.

Benefits

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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