IT Validation Lead

Are you driven by the desire to ensure the integrity of IT systems through rigorous validation processes? Do you thrive in an environment where quality and efficiency are paramount, and robust validation frameworks are the norm? If so, we invite you to apply for the position of IT Validation Lead in our Compliance, Test & Validation team.
The Position
As an IT Validation Lead, you will be a key player in a dynamic team that delivers digital solutions for complex processes. Your primary role will be to define and execute validation and qualification strategies for GxP Computerised Systems, Computerised Equipment, Infrastructure, Robotic Process Automation (RPA), and emerging technologies such as Artificial Intelligence (AI) and Machine Learning (ML), both in the project and operation phase. Your main responsibilities will be to:
•Develop and implement our Validation Framework across our process automation solutions
•Identify and address validation gaps, ensuring our IT systems meet all relevant regulations and standards
•Increase validation capabilities through staff training, empowering our staff to maintain and enhance validation in their workManage end-to-end validation and qualification tasks, encompassing validation planning, report generation, design review, test strategy development, and execution
•Conduct diverse assessments including Supplier, IT risk, IT requirements risk, and functional and data integrity assessments
•Maintain system validation through regular reviews, deviation handling, and collaboration with System Managers and IT personnel to create and update system documentation and instructions as necessary
You will report to the Head of Compliance, Test & Validation, Volker J. Jentzsch (VJZ), and be based in our new offices in Ballerup, Denmark. Qualifications
We are seeking a motivated team player with a proven track record in implementing validation frameworks. You should thrive in an agile and dynamic environment, be comfortable with rapidly changing priorities, and enjoy challenging the status quo. The ideal candidate for this position should meet the following requirements: •B.Sc. or equivalent in a relevant field
•Demonstrated experience in a similar role, with a track record of successfully implementing validation frameworks and validation automation
•Strong knowledge of IT GxP validation, preferably in a regulated industry such as pharma or healthcare
•Relevant certifications certifications such as GAMP5, CSQE, CVP, CQA, CQE, CRMA, CISA, or CRISC
•Proficient in Organizational Change Management, including staff training and capability development, with a focus on fostering adaptability and readiness for change
•Skilled in Process Flow Analysis/Value Chain Mapping, adhering to LEAN principles, to optimize efficiency and identify areas for improvement in workflows and operations As a person, you are an ambitious and innovative team player who has a result-oriented way of working. You approach tasks with a high degree of structure, energy, curiosity, and a positive attitude. You have a flair for collaborating with a broad range of stakeholders. Most importantly, you are passionate about powering digital transformation across the entire value chain! The Department
Our team's mission is to equip the Line of Business with the best practices for compliance, testing, and validation of digital solutions. We are committed to ensuring that locally developed digital solutions are ready for inspection at any time, adhering to the precise regulations and standards that govern our industry.
We take a proactive approach to compliance, emphasizing prevention over cure. We stay updated with the latest regulations and standards, minimizing non-compliance risk and ensuring our solutions follow best practices. Our goal is to ensure digital solutions are fit for their intended use and provide genuine value to our customers across [xxxxx].
A key part of our strategy is test automation, which increases efficiency, reduces human error risk, and allows our team to focus on more complex testing scenarios. We guide a thorough testing process designed to detect and mitigate potential risks. Discover the cutting-edge technologies behind [xxxxx]'s life-changing innovations at Tech.life at [xxxxx]. From AI to quantum computing, our digital experts push boundaries and make a tangible impact on lives across the globe. You don’t want to miss it. Working at [xxxxx]
[xxxxx] is a global healthcare company headquartered in Denmark. For 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases. We are proud of that. We are proud of our people too, and we employ more than 57,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change lives for people worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued. That said, opportunities are many in [xxxxx].
Contact
For further information, please contact Head of Compliance, Test & Validation, Volker J. Jentzsch, at [xxxxx] Deadline
21 April 2024 Feeling overwhelmed by job requirements and doubting if you're 100% qualified? Don't let it stop you! We encourage you to apply anyway, as your profile could surprise us and fit our needs better than you think. So, take the leap and submit your application.
To ensure a fair and equal recruitment process, please refrain from adding a picture in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.