AI-ML Compliance Lead

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.

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. 

That’s what makes us Roche.

As the recently formed Global Digital Compliance within the Pharma Technical Operations (PT) Quality organization, we enable the delivery of regulatory-compliant digital solutions with our customers to bring actionable insights and leadership for compliant outcomes for Pharma Technical Operations (PT).
  

In Digital Compliance, we partner across primary global business functions – PTQ, PT Digital & Operational Excellence (PTE), PT-Development, PT-Regulatory, and PT-Manufacturing, and our partners in Global Informatics. Together, we will build a solid cross-functional and inclusive community, put the power of data into the hands of our people, further develop Lean and Digital skills across PT, and scale up our Digital and Advanced Analytics solutions for the benefit of our colleagues and patients.

The Opportunity:

We are looking for a mid-level AI/ML & Digital Quality Lead to provide Quality Assurance guidance for teams designing and implementing cutting-edge AI/ML/Digital solutions in a GMP Environment. If you have a passion for innovation and a proven track record in supporting AI/ML systems, this role is made for you.

• You provide quality and compliance oversight for teams designing and implementing the AI/ML Systems Governance Framework to support GMP business objectives.

• You identify business needs with stakeholders and propose AI/ML technical solutions.

• You develop and maintain a comprehensive understanding of the organization's technical landscape, data infrastructure, and processing pipelines.

• You provide oversight to the design and implementation of accurate, efficient, scalable, secure, and GMP-validated AI/ML models.

• You collaborate with the data science team to select and implement the right algorithms and models for specific business problems.

• You work with the software development team to integrate AI/ML systems into existing business applications.

• You develop and maintain documentation for AI/ML systems and ensure compliance with regulatory requirements, staying updated on emerging AI/ML technologies.

Who you are 

• You hold a BS/MS degree or equivalent in Science, Computer Science, or Engineering, with  5 years of experience in a regulated industry such as pharma/biotech or medical devices You bring relevant work experience or an equivalent mix of education and work experience.

• You possess proven experience in designing and implementing AI/ML systems, preferably in the pharmaceutical, biotech, or medical device industry.

• You have strong knowledge of AI/ML technologies, including deep learning, NLP, computer vision, LLMs, and AI agent workflows, along with Pharmaceutical Regulations (FDA/EMA) and AI Risk Management Frameworks.

• You understand the significance of data quality in the AI/ML lifecycle and have experience monitoring AI/ML solutions in operation.

• Familiar with experience in GxP computerized systems, validation framework and  AI Industry standard E.G: ISO’s

• You have strong knowledge of programming languages (Python, R, Julia) and data processing/storage technologies (Hadoop, Spark, NoSQL), as well as experience with cloud platforms (AWS, Azure, Google Cloud) and ML Ops.

• You possess excellent problem-solving, analytical, communication, collaboration in a team, ability to work in a fast paced environment with diverse technical experience in AI model development, software engineering, quality and risk management, monitoring deployed software, and building secure software in compliance-based environments.

Relocation benefits not eligible for this position 

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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.