Computer System Validation Lead, Digital Solutions - Biometrics
Are you looking for an exciting opportunity to make a difference in the lives of people with brain diseases? Do you have an interest in ensuring compliance and quality in computer system validation? If so, we have the perfect opportunity for you!
We are looking for a dynamic and forward-thinking Computer System Validation Lead to join our Digital Solutions department.
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Your new role – why is this a great opportunity?
As our new Computer System Validation Lead in Digital Solutions, you will be part of an agile and collaborative team that is committed to bringing innovative solutions to the challenges faced by people with brain diseases. You will have the opportunity to work on an array of interesting projects together with a wide range of experts across the Global Clinical Development organization.
You will be responsible for ensuring that our computerized systems and software applications comply with regulatory requirements and meet our company's quality standards.
Our team works on Clinical Data and Operational Data from clinical trials, and your primary focus will be on ensuring the validation of our computer systems, both on premise and in the cloud, used to process, analyse, and report this data. You will be working closely with colleagues in Biometrics, Global Clinical Development, Global IT and Quality Assurance departments, as well as with external consultants.
In addition, you will be the validation lead for several projects requiring validation in a GxP environment ensuring that knowledge is shared across system owners and the team members, so that validation is done homogeneously across systems. Furthermore, you will coordinate preparations in Biometrics for regulatory inspections and act as our anchor person during and after inspections.
Your future team
The Digital Solutions department consists of 8 highly skilled and engaged employees. The department is part of the Biometrics Sciences Division. Our key responsibilities are to develop data flows and to implement clinical applications as well as data visualizations utilized in all stages of our clinical development, and by many different colleagues across Global Clinical Development.
The system landscape includes industry standard systems, such as Medidata Rave®, SAS®, EntimICE®, Spotfire®, R, Python® and Oracle® and is complemented with applications developed specifically tailored to Lundbeck’s requirements. We also work with a combination of on premise and cloud-based systems.
What you bring to the team
You are a highly skilled Computer System Validation Lead and hold a master's degree in computer science, engineering, or related field. You bring at least 5 years of experience in computer system validation from a pharmaceutical or biotech company and possess extensive knowledge of regulatory requirements related to computer system validation such as FDA's 21 CFR Part 11, GAMP5, and other applicable regulations and guidelines.
In addition, you have experience in:
- Developing and executing validation protocols and writing validation documentation, both for systems on premise and in the cloud
- Leading computer system validation projects, managing timelines and resources, and ensuring successful project completion
- Collaborating effectively with cross-functional teams and stakeholders
Our promise to you
Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.
You can also learn more about us at www.lundbeck.com or by following us on LinkedIn, Instagram (@h_lundbeck) or Twitter (@Lundbeck).
Apply now
Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!
Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.
If you have questions or want to hear more, please feel free to contact Rindra Andrianantenaina, Senior Manager, on tel. +45 30 83 26 77. Applications must be received by June 16, 2023.
We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.
#EveryBrainInTheGame
To external agencies: Lundbeck does not accept unsolicited requests or candidates from search firms. We ask you to respect this policy by refraining from contacting our employees about this position.
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