The company has a passion for improving patients’ lives all over the world. Will you help bring that passion to life? Would you like to further develop your expertise within validation and quality control? We are looking for a skilled IT Validation Lead to help drive the digital transformation – join us today.

Play your part in System Operations and Compliance

This is a dedicated team of 14 people anchored in Research and Early Development IT (R&ED IT), responsible for developing, implementing, validating, and operating more than 30 regulated laboratory IT systems used within the non-clinical and clinical early development area of the company, and now expanding. From this role as IT Validation Lead, you will participate in a cross-organisational Agile Release Train within the GlobalLIMS system.

The team works together as part of an agile, collaborative, and learning work environment, where professional integrity and shared responsibility are key. R&ED IT is part of Digital, Data & IT (DD&IT) – a global community of 2,100+ colleagues driving digital, data, and IT to support digital transformation and innovation across the value chain, from idea to patient.

IT Validation Lead

As a validation lead, you will be responsible for defining the validation strategy, validation planning, and reporting concerning a specific implementation or upgrade of an IT system with GxP (healthcare) impact. You will work closely with product owners, Line of Business (LoB), and other stakeholders to understand the scope of validation and act as liaison with LoB QA and ITQA.

This is a job for those who are excited to work with technologies, validation, testing, and quality control in agile IT projects. Key tasks include:

• Participating in large-scale IT projects as the validation expert, responsible for the execution of validation and quality control activities
• Taking responsibility for all validation activities for the project(s), e.g. planning, documentation, coordination, and reporting, ensuring these are executed effectively
• Helping develop and optimise the approach to validation and quality control work, ensuring the right things are tested and validated at the right level, supporting a risk-based approach to testing
• Performing various assessments such as Supplier Assessment and IT risk assessment, or facilitating workshops for these activities
• Ensuring the validated state of the system(s) by performing periodic reviews, addressing deviations, and creating and maintaining system documentation and instructions in cooperation with system managers and IT responsible when needed
• Ensuring that systems follow relevant internal and external regulatory requirements
• Participating in audits and inspections, including finding solutions to compliance gaps identified during audits and inspections
• Helping development teams develop and maintain test plans, test scripts, and user acceptance tests, and managing the execution of test plans

What are we looking for?

You are proactive and thrive in a challenging, dynamic, and ever-changing environment. You can handle several tasks at a time and keep an ongoing focus on results. You are open-minded, positive, and collaborate well with external parties, customers, vendors, and consultants.

• A bachelor’s degree or similar graduate degree within relevant fields
• 2+ years of experience within IT Validation from the pharma industry or other regulated industries
• Experience working with large-scale projects, preferably in an agile manner
• Process-oriented with good documentation skills
• Familiar with change management

Join the company

The company doesn’t wait for change — it drives it. It’s a dynamic company in an even more dynamic industry, embracing the spirit of experimentation and striving for excellence without fixating on perfection. From research and development, through to manufacturing, marketing, and sales, everyone works to move the needle on patient care.