Senior Team Lead, IT & Digital Validation

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

The Role

The IT and Digital (IT&D) Validation Team Lead plays a central part in the quality assurance and acceptance of Genmab’s computer systems. As Senior Team Lead, you facilitate a strong connection between business stakeholders, the Quality Assurance department, and the IT&D department, and forges close cooperation between Genmab colleagues on many levels.

The IT&D Validation Team Lead guides IT&D implementation projects and selected IT&D initiatives towards the level of qualification and validation that the projects and initiatives should cover and advises on the correct level of documentation. Genmab Quality Assurance is shifting from more traditional SDLC (Software Development Life Cycle) and CSV (Computer system Validation) to CSA (Computer Software Assurance), which demands a critical approach to documentation and testing. The validation expertise must be combined with a strong testing mindset.

This role will manage other external validation resources and maintain quality assurance procedures and processes to ensure that quality assurance is met for Genmab’s computer systems.

This new Team Lead will report directly to the Portfolio and Finance Tower Lead within IT&D.

Responsibilities

• Responsible for bridging the Quality Assurance demands on IT&D Projects and initiatives by maintaining an IT&D Validation Framework with templates

• Ensure external Validation Leads are working on the right deliverables at the right level of documentation towards a consistent validation package

• Deliver according to Genmab’s Computerized system validation and software assurance SOP (Standard Operating Procedure)

• Ensure timely communication and coordination of risks, activities, testing execution, and reporting

• Ensure initiation/preparation and closeout of all validation related deviations, discrepancies, and change control documents

• Provide recommendations for resolving deviations from established processes

• Help project and product teams develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans

• Coordinate project reviews of internal computer systems validation activities, protocol, and procedures, and prepare responses

• Act as a Validation Lead for validation projects

• Evaluate proposed changes to validated systems and recommend level of validation activities required, in close cooperation with IT QA

• Support project management activities for validation projects

• Assist with the development of system requirements and specifications to ensure requirements are testable and met

• Execute or oversee the execution of validation plans and validation documents

• Coach the implementation teams in the proper execution of validation documents

• Preapprove test scripts before and after they are executed

• Availability to travel (when appropriate)

Requirements

• 10-12 years of experience in computer system validation and assurance, preferably in a biotech or pharmaceutical company

• Good knowledge of quality management, including 21CFR Part 11 and GAMP

• Results driven with a strong customer and quality focus

• Hands on experience using Agile and Test Management applications

• Multiple years of process improvement experience, especially experience that leverages technology as part of the solution

• Hands-on experience with test modeling, analysis, and simulation tools

• Experience working on projects using a variety of testing methods

• Track record of working on projects that delivered different types of business outcomes

• Ability to work on multiple projects concurrently with good organization skills

• Business domain experience in the process areas being supported

• Excellent interpersonal skills, verbal, and written communication, including great presentations

• Strong analytical and conceptual skills

• More interested in business results than personal preferences, and in group rather than individual achievement

• Negotiating and networking, including conducting teambuilding activities

• Being dynamic and self-motivated and thrive in working in a diverse environment

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.



At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy.

Scam alert

Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation.  This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.