At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The PositionIT Quality Specialist RDT DIA R&DRoche Digital Technology (RDT) is where innovation meets purpose. As a global team at the heart of Roche, we are a community of business-minded technologists committed to help shape tomorrow’s digital future of healthcare. Our mission is to power Roche through cutting-edge digital technologies, harnessing the potential of artificial intelligence, data, and scalable tech innovations. Driven by purpose and passion, we’re building a future where digital is a core strength across all of Roche, enabling smarter ways of working, unlocking human potential, and driving breakthroughs that truly matter for millions of patients around the world.
At Roche, we offer a hybrid work model that combines flexibility with in-person collaboration. For now, we require our employees to be in our offices on average two days per week. The specific office days may vary depending on business needs, such as workshops, conferences, town halls, team meetings, and other collaborative events.
Working as an IT Quality Specialist, you are part of a global community focused on developing and validating cutting-edge software and COTS systems within Roche’s Diagnostics R&D. In this role, you act as a Computer System Validation (CSV) Subject Matter Expert, bridging regulatory excellence with a lean, innovative approach to digital healthcare solutions.
The opportunity:
- Driving global validation efforts by providing expert guidance and authoring critical CSV documentation, including plans, reports, and risk assessments, across diverse delivery frameworks.
- Ensuring full alignment with GxP, ERES, and internal Roche standards while overseeing periodic system evaluations to uphold continuous audit readiness.
- Partnering with Business and Quality stakeholders as a trusted consultant to facilitate cross-functional collaboration and streamline resolution within product teams.
- Evaluating the impact of changes on validated states to protect data integrity and supporting the growth of scalable digital healthcare solutions in complex environments.
Who you are:
- Possessing a minimum of six years of professional experience in CSV, specifically supporting the lifecycle of COTS and custom software within regulated GxP environments.
- Holding a University degree in Science, Engineering, or Computer Science; equivalent technical backgrounds are also highly valued.
- Demonstrating profound expertise in global regulations, including FDA/EU GxP, 21 CFR Part 11, GAMP 5, and the core tenets of Data Integrity.
- Expertly navigating diverse testing methodologies and the end-to-end SDLC within modern Agile frameworks such as Scrum or SAFe.
- A collaborative team player with fluent English skills, comfortable mentoring peers and thriving within international, cross-functional project teams.
- Familiarity with Product Development Processes specific to Medical Devices is considered a distinct advantage.
What you get:
- Salary range 14 175-26 325 PLN gross based on the employment contract.
- Annual bonus payment based on your performance.
- Dedicated training budget (training, certifications, conferences, diversified career paths etc.).
- Recharge Fridays (2 Fridays off per quarter available).
- Take time Program (up to 3 months of leave to use for any purpose).
- Vacation subsidy available.
- Flex Location (possibility to perform our work from different places in the world for a certain period of time).
- Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice).
- Private healthcare (LuxMed packages), group life insurance (UNUM) and Multisport.
- Stock share purchase additions.
- Yearly sales of company laptops and cars and many more!
If you feel this offer suits a friend of yours, feel free to share it.
Want to know what it’s like to be a part of Roche IT first-hand? Check out our blog!
https://careers.roche.com/global/en/we-are-roche
…..
The controller of your personal data is Roche Polska Sp. z o.o., ul. Domaniewska 28, 02-672 Warsaw. The data is processed for the purpose of recruitment. You have the right to access your data, rectify it, delete it, limit processing, transfer it and - if processing is based on your consent - withdraw this consent at any time. Contact the Data Protection Officer at: [email protected]. More information on the principles of processing your personal data by Roche at the link:https://www.roche.pl/pl/content/klauzula-informacyjna-rekrutacja-en.htmlRoche Polska sp. z o.o. operates in full compliance with the law and does not tolerate any violations. Roche Polska sp. z o.o. has implemented a Procedure for Reporting Violations of Law. If you wish to report any irregularities related to our activities, all necessary information regarding the reporting process can be found on our website: https://www.roche.pl/kontakt/ochrona-sygnalistow-zglaszanie-naruszenCompensation & BenefitsThe expected salary range for this position, based on the primary location of Warsaw Grafit is 170’100.00 PLN-315’900.00 PLN. Final compensation will be determined by a number of factors, including your skills, experience, qualifications, and location. In addition to base pay, this role may be eligible for a discretionary annual bonus with a target of 15% subject to both individual and company performance.
This position also offers an attractive benefits package.
Learn more about how we reward our employees at Roche.
Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Skills Required
- Minimum six years of professional experience in CSV
- University degree in Science, Engineering, or Computer Science
- Expertise in FDA/EU GxP, 21 CFR Part 11, GAMP 5
- Experience with testing methodologies and SDLC in Agile frameworks
- Fluent English skills
- Familiarity with Product Development Processes for Medical Devices
Roche Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Roche and has not been reviewed or approved by Roche.
-
Strong & Reliable Incentives — Performance bonuses and profit-sharing are integral components of total rewards, with variable pay linked to individual and company outcomes. Long-term incentive programs and an employee stock purchase plan further reinforce consistent incentive opportunities.
-
Healthcare Strength — Coverage spans medical, dental, vision, life, and disability insurance alongside mental health support and flexible spending accounts. Wellness resources such as fitness stipends and wellbeing programs broaden healthcare value.
-
Parental & Family Support — Support includes parental leave, adoption assistance, childcare benefits, and family medical leave, with some locations offering extended maternity leave. Family allowances and flexible working models reinforce accommodations for caregiving needs.
Roche Insights
What We Do
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
