AI/ML Compliance Lead — Roche
- Location
- Basel
- Contract
- full-time
- Posted
- Yesterday
Role overview
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.
- 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.
Application process
- Collaborate cross-functionally with data science, software development, and IT teams to integrate AI/ML algorithms into business applications under a standard Computer System Validation (CSV) and Computer
- Software Assurance (CSA) framework.
- Author, review, and approve critical validation documentation, including validation plans, technical specifications, system architecture diagrams, and test scripts.
- Identify and proactively mitigate quality, security, and data privacy risks across the full AI/ML lifecycle, addressing issues such as model drift, dataset bias, and validation boundaries.
- Influence and align diverse technical and operational stakeholders across global business units to establish compliant validation strategies for advanced digital solutions.
- Drive continuous improvement initiatives that streamline CSV/CSA processes, integrating emerging AI risk management frameworks into existing quality management systems.
- Mentor and coach colleagues across Digital Compliance and broader Quality functions, fostering an agile mindset and supporting capability building in digital validation. Who you are
- You hold a BS/MS degree in Science, Computer Science, Engineering, or a related field, backed by 5-7 years of relevant experience in a regulated pharmaceutical, biotech, or medical device environment.
Additional details
- Join Roche, where every voice matters.
- By working closely with technical teams, you will ensure AI/ML solutions are accurate, efficient, scalable, secure, and validated for GMP use.
- Mentor and coach colleagues across Digital Compliance and broader Quality functions, fostering an agile mindset and supporting capability building in digital validation.
- You are deeply knowledgeable in FDA/EMA pharmaceutical regulations, GAMP 5, 21 CFR Part 11, Annex 11, and core Quality Risk Management principles (ICH Q9 / ICH Q10). You bring functional exper
Notes and original content
- The Position
- The Opportunity
- Who you are
- You are deeply knowledgeable in FDA/EMA pharmaceutical regulations, GAMP 5, 21 CFR Part 11, Annex 11, and core Quality Risk Management principles (ICH Q9 / ICH Q10).
- You bring functional exper
Questions about this listing
What salary does Roche offer for this role?
Roche lists CHF 85'500 - 129'500 gross per year for this position in Basel. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Roche offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Roche during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Roche?
Use the "Apply now" button on this page — it links directly to Roche's original listing at roche.wd3.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
