Principal QA Information Systems Engineer

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 are motivated by a single purpose: Doing now what patients need next. As a global leader in healthcare and a pioneer in pharmaceuticals and diagnostics we are dedicated to transforming the lives of patients through ground-breaking science and innovation. With a history spanning over 125 years our commitment to excellence and our passion for improving human health have made us one of the worlds most influential healthcare organizations. By joining Roche you become part of a diverse and inclusive community of experts focused on delivering personalized healthcare and pushing the boundaries of medical possibility.

The Opportunity

As a Principal QA Information Systems Engineer within our Cell & Gene Therapies (CGT) team you will be at the forefront of delivering life-changing individualized treatments. You will provide critical quality oversight and technical expertise to ensure our enterprise systems and CGT-specific applications are robust compliant and innovative.

• Serve as the primary Quality Subject Matter Expert (SME) for CGT ERP systems and technical applications including orchestration and exceptions management systems.

• Collaborate with global cross-functional teams to define design deploy and maintain enterprise systems that strictly adhere to regulatory requirements and quality standards.

• Translate complex business needs into streamlined process flows and detailed user requirements by leveraging deep expertise in SAP and relevant technical platforms.

• Develop implement and lead a comprehensive data integrity program that remains compliant with evolving global regulatory standards and industry best practices.

• Directly support internal and external audits manage deviations/CAPAs and oversee the resolution of IT-related quality records to safeguard product traceability.

• Drive continuous improvement initiatives within Roches Quality Management System (QMS) to align our policies and procedures with emerging global regulations.

• Act as a strategic bridge between Manufacturing Quality IT and Supply Chain to ensure seamless implementation and compliance of all CGT-supporting technologies.

Who you are

You are a visionary technical leader with a passion for quality and the ability to thrive in a high-stakes matrixed global environment. You combine deep regulatory knowledge with the agility required to support the next generation of medical therapies.

• You possess a Bachelors or Post-Graduate degree in Science Engineering or a related field supported by at least 10 years of quality experience in the pharmaceutical or biotech industry.

• You demonstrate deep expertise in Cell & Gene Therapy (CGT) alongside a profound understanding of GxPs FDA/EMA regulations and global data integrity requirements.

• You are skilled at collaborating with and influencing stakeholders across diverse functions and geographies within a complex global organization.

• You exhibit a proactive can-do attitude with the analytical precision necessary to solve complex problems and drive results in evolving technical landscapes.

• You are an exceptional communicator capable of distilling both strategic objectives and tactical solutions into clear concise and impactful messaging.

• You possess advanced negotiation and influencing skills enabling you to achieve critical outcomes with global operations external partners and suppliers.

• You are highly adaptable and culturally aware with the autonomy to manage multiple priorities and the willingness to travel internationally to support our global mission.

***Relocation benefits not eligible 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.