IT Quality Specialist - RDT DIA R&D

Descrizione del lavoro:

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 Position

IT Quality Specialist

Roche 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.

As an IT Quality Specialist, you will independently provide strategic direction for quality and validation activities across the DIA R&D organization. You will be part of global teams responsible for developing, validating, and implementing innovative software solutions for patients and COTS computerized systems in Roche's Diagnostics division. As a senior subject matter expert in Computerized System Validation and quality processes, you will provide oversight and mentoring for validation leads within the department.

The opportunity:
* Validation Leadership: Coordinate global validation activities for DIA R&D Labs. Author and review CSV deliverables across Waterfall, Agile, and Hybrid methodologies.
* Compliance & Governance: Act as Information Security Coordinator (ISC) and CSV subject matter expert. Lead periodic reviews and ensure audit readiness per Roche policies.
* Strategic Impact: Manage the System Compliance Maturity Dashboard and assess system changes to maintain a validated state. Contribute to organizational best practices and Communities of Practice (CoPs).
* Stakeholder Management: Partner with Quality departments to ensure regulatory alignment. Act as a trusted advisor across multiple product squads, facilitating workshops and resolving conflicts.
* Problem Solving: Apply a "lean and innovative" mindset to complex validation challenges without compromising quality standards.
* Mentorship: Lead by example, mentoring junior staff and championing accountability across the organization.
* Technical Expertise: Independently manage requirements, data usability, and process analysis within the R&D domain.
* Complexity Management: Navigate ambiguous requirements and interdependencies across large-scale, complex products.

Who you are:
* Experience: 10+ years in CSV (COTS & custom software), ideally in GxP environments. Bachelor's in Science, Engineering, or IT.
* Regulatory Knowledge: Expert in FDA/EU GxP, 21 CFR Part 11 (ERES), PIC/S, EU Annex 11, GAMP 5, TIR045, and Data Integrity (MHRA/FDA).
* Documentation: Expert in authoring/reviewing VP/VR, TP/TR, URS, FRS, SRA/FRA, SAT, UAT, and TM.
* Technical Skills: Proficient in IRM (Security/Privacy/Regulatory), diverse testing types (exploratory, regression, unscripted), and SDLC/Agile (Scrum/SAFe).
* Strategy & Analysis: Strong ability in requirements/data analysis, evaluating solution impacts, and PDP for Medical Devices.
* Leadership: Experience with global teams, fluent English, and a proven track record of mentoring junior staff and driving process improvements.

What you get:
* Salary range 19 075 - 34 425 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!

Apply directly and join us in shaping the future of healthcare.

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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

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Roche 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-naruszen

Compensation & Benefits
The expected salary range for this position, based on the primary location of Warsaw Grafit is 228'900.00 PLN-425'100.00 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 20% 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 are

A 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