Global MSAT Scientific Expert (Validation & Systems)

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

At Roche we believe every person should have access to the best healthcare possible and we are committed to making this a reality. As a global leader in pharmaceuticals and diagnostics we focus on advancing science to improve lives and develop innovative solutions that address some of the worlds most pressing medical needs. Our culture is built on a foundation of integrity courage and passion fostering a collaborative environment where every individual has the opportunity to contribute to a healthier future. Joining Roche means being part of a multinational community dedicated to excellence and driven by the purpose of doing now what patients need next.

As a vital member of the Global MSAT & Engineering team (PTT) you will ensure the integrity and compliance of our global validation systems in alignment with cGMP regulations and Roche standards. This expert-level role focuses on developing innovative validation strategies optimizing Qualification/Validation business processes and resolving complex technical challenges across the global network. By collaborating with MSAT Engineering Quality and IT organizations you will act as a technical leader and network collaborator to drive the implementation of effective compliant solutions across the enterprise.

The Opportunity

• Drive the development and implementation of sustainable global validation system strategies to ensure unwavering compliance with cGMP regulations and Roche standards.

• Optimize and build Qualification and Validation business processes across the enterprise aligning them with international industry best practices.

• Lead risk assessment initiatives to proactively identify system compliance issues and architect robust mitigation plans for global manufacturing sites.

• Collaborate with cross-functional leadership in Quality Manufacturing and Engineering to harmonize validation activities and foster integrated technical solutions.

• Act as a primary thought partner to senior management translating complex technical validation challenges into actionable strategic insights.

• Spearhead enterprise-wide change management and training programs to accelerate the adoption of advanced validation systems and principles.

• Manage the end-to-end lifecycle of Master Data and templates within Validation Lifecycle Management Systems (VLMS) ensuring seamless deployment across the global network.

Who you are

• You possess an advanced degree (Masters or PhD) in Engineering Life Sciences or a related technical field underpinned by over 10 years of experience in the pharmaceutical or biotech industry.

• You are an expert in GxP regulatory requirements including FDA EMA and ICH standards specifically within 21 CFR Part 11 compliant environments.

• You bring a proven track record of matrix leadership demonstrating the ability to influence and lead cross-functional teams toward common strategic goals.

• You are highly proficient in validation methodologies and have significant experience working with Val Genesis or similar Validation Lifecycle Management Systems.

• You demonstrate exceptional project management skills with the ability to lead enterprise-level initiatives from initial requirement analysis through to final implementation.

• You are a decisive communicator with the executive presence needed to present complex data and potential solutions to senior stakeholders effectively.

• You possess a coaching mindset committed to mentoring colleagues and fostering a culture of technical growth and continuous improvement within the global network.

Anticipated domestic and international travel: < 10%

***Re-location benefits not available for this position***

We use artificial intelligence to screen assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.