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Madrid, Comunidad de Madrid, España
Hybrid
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.
Are you ready to reshape IT compliance into an agile business enabler? As an RDT Quality Assurance & Compliance Specialist, you won't be a gatekeeper; you will be a Catalyst within Roche Digital Technologies.
Our mission is to empower IT teams to deliver quality efficiently, right the first time. You will apply smart regulatory guardrails to cutting-edge technologies—including Cloud Computing, Machine Learning, RPA, DevOps, and SAFe.
If you thrive on transforming compliance into an automated, data-driven framework, join us!
Agile IT Compliance Consultancy: Provide expert guidance on CSV, GDPR, Data Integrity, and ICFR for dynamic project and system delivery teams.
Quality & Risk Oversight: Oversee validation, qualification, and system risk assessments across assigned Informatics systems.
Future Quality Framework: Co-create SOPs, checklists, and guardrails for our Informatics Quality Management System, keeping it aligned with evolving external standards.
Audits & Control: Co-audit internal/external IT processes, conduct periodic system reviews, and define control specifications based on global policies.
Coaching & Continuous Improvement: Train delivery teams on Built-In IT Compliance and data integrity, fostering a culture of quality ownership.
Experience: 2+ years in IT Quality Assurance (Validation Lead, Quality Management, Auditing), preferably in pharma/healthcare.
Regulatory Expertise: Strong knowledge of CSV, Data Integrity, ICFR, and GDPR.
Agile & Tech Savvy: Proven experience in SCRUM/SAFe and adapting compliance to Cloud, RPA, and Machine Learning.
Mindset & Skills: Systematic thinker, skilled in data-driven automation, and adept at influencing diverse, global virtual teams.
Languages: Excellent English communication skills. Willingness for occasional travel.
Bonus Points: Experience in SOC 1/2 reporting, CISA, or Lean Six Sigma certifications.
Impact & Innovation: Reframe compliance as a driver for digital transformation alongside state-of-the-art tech.
Global Exposure: Connect and grow within a multicultural, global network.
A Culture of Belonging: Diversity and inclusion are vital to our success. We warmly encourage candidates with disabilities to apply, offering dedicated benefits, tailored support, and an inclusive workplace where you can truly thrive.
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.
