UCR

Are you an experienced validation lead for computerized systems who enjoys working from a risk-based approach and implementing pragmatic solutions? Do you thrive on creating order and clarity, but can also see different solutions for different tasks?

Then you should work with us at UCR!

About us

UCR is Sweden's leading academic clinical research organization (ARO). We provide expertise to both academia and industry in all aspects of clinical research and quality follow-up. Since our start in 2001 at Uppsala University and the Academic Hospital, we have developed a complete operation that covers the entire research process – from planning and execution to analysis, reporting, and publication.

With us, you will work in an innovative environment with engaged colleagues who strive to improve people's health through research.

About the role

We are now looking for a validation lead who wants to strengthen our QA team at UCR. As a validation lead with us, you will take the lead in our work with validation, change management, periodic review, and decommissioning of computerized systems. The systems are cloud-based, installed on UCR's infrastructure, or custom-developed and are used in clinical trials, studies, and UCR's operations. Always with the aim of improving healthcare for people in Sweden and around the world.

You will not start from scratch but from a base of SOPs and instructions. QA and other colleagues who have previously managed the area will support you with their experiences, but you will be the one to stitch the process together with us and become our guiding star in the field.

Responsibilities:

• Validation process, validation strategy, validation documentation
• Validate computerized systems
• Coordinate validation activities and lead resources in projects where both clients, suppliers, and employees may be involved
• Deviations and change requests related to validated computerized systems
• Requirements specification, testing, and risk management
• Training in validation

Who are we looking for

We are looking for someone with strong leadership and collaboration skills. You are structured and self-driven, with the ability to push work forward and build a pragmatic process. You have both a holistic perspective and a detail focus – you create strategic plans but can also handle technical details when needed.

You are communicative and pedagogical, and can clearly explain validation requirements and processes to different target groups. Through good collaboration skills, you create engagement and utilize the organization's expertise to shape a common path forward. Furthermore, you are a solution-oriented problem solver who identifies and manages challenges in the validation work.

You take responsibility, drive improvements, and ensure that systems and processes are robust. Finally, you are flexible and adaptable, with the ability to handle changes effectively.

Your qualifications

• Several years of experience in validation (CSV), change management, periodic review, and decommissioning of computerized systems
• University or college education or have gained similar experience in another way
• Good knowledge of GAMP5 and other relevant regulations and guidelines
• Experience in writing requirements and tests as well as conducting risk analyses (both at a high level and in detail)
• Fluent in Swedish and English, both spoken and written

Meritorious

• ISTQB certified (or similar certification)
• Experience in agile system development
• Work at UCR

With us, you will receive benefits that make a difference, read about the benefits here (https://regionuppsala.se/jobba-hos-oss/bli-var-nya-kollega/formaner/ (https://regionuppsala.se/jobba-hos-oss/bli-var-nya-kollega/formaner/)).

Want to know more?

Jessica Magnusson, QA Manager
Jessica.magnusson@ucr.uu.se (mailto:Jessica.magnusson@ucr.uu.se)
072 207 09 23

Katarina Boustedt, HR
katarina.boustedt@ucr.uu.se (mailto:katarina.boustedt@ucr.uu.se)
076 722 50 16

Union representatives

SACO: susanna.thornqvist@ucr.uu.se (mailto:susanna.thornqvist@ucr.uu.se)
Vision: Johanna.vintersved@ucr.uu.se (mailto:Johanna.vintersved@ucr.uu.se)

Do you want to work with us?

With us, you will have a stimulating and varied job in an organization that makes a real difference for people's health. You will become part of an engaged and professional organization where your contribution helps to drive clinical research forward – both nationally and internationally.

Does this sound like a role for you?

We offer a permanent full-time position with a start date according to agreement. We are located in premises in Uppsala Science Park.

Welcome with your application via the link below.

Region Uppsala values the qualities that a balanced gender distribution and diversity bring to the organization and welcomes applicants of all genders and with different backgrounds, abilities, and life experiences.

Region Uppsala places all permanent staff based on the needs of total defense. This means that for the individual employee, there are no obligations in peacetime but is solely a planning measure.

Before a hiring decision is made, a check of the suspicion and criminal record regarding all applicants who may work in psychiatric care, habilitation, care of children and youth, or involuntary care of substance abusers will take place.

This recruitment is conducted entirely through Region Uppsala's efforts, and we kindly ask recruitment companies and advertisement sellers not to contact us.