Regulatory Innovation & Sustainment Professional Quality & Compliance

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. Its 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. Thats what makes us Roche.

As a Regulatory Innovation & Sustainment Professional within Pharma Development Regulatorys (PDR) Quality & Compliance capability you will be accountable for creating and maintaining PDRs Quality Management System (QMS) framework. This includes fostering innovation identifying and implementing continuous improvement opportunities and developing risk-based quality strategies.

• Act as a trusted partner to senior business stakeholders leading or supporting cross-functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes.

• Collaborate with global teams to mature and sustain PDRs Quality & Compliance capabilities.

• Monitor external trends and regulatory changes to ensure ongoing readiness.

• Identify opportunities for continuous improvement and drive strategic change initiatives.

• Lead internal/external audits Health Authority inspections and risk assessments.

• Ensure compliance with global regulatory standards including Good Clinical Practice / Good Pharmacovigilance Practice (GCP/GVP) and Medical Device related requirements where applicable.

• Optimize processes to enable operational excellence and maintain our license to operate.

• You have a Bachelors degree or equivalent in a scientific or quality-related field (an advanced degree is preferred).

• You have a minimum of 7 years of experience in Quality & Compliance Regulatory Affairs or Drug and/or Device Development with a strong understanding of regulated environments industry frameworks data and digital systems.

• Youre a strategic thinker and problem solver who thrives in a fast-paced collaborative environment driven by purpose excited by innovation and confident in influencing change across a complex organization.

• You are skilled at analyzing complex quality data and translating these insights into clear actionable executive reporting and strategic messages.

• You possess exceptional verbal and written communication skills with proven ability to communicate and collaborate effectively across global/local matrixed teams and senior leadership.

• You possess a continuous improvement mindset and a proactive approach to solving challenges with the ability to assess end-to-end processes identify inconsistencies and improve process effectiveness and efficiency.

• You can influence best practice adoption.

• Experience with audits or inspections is a plus but not essential.

**Relocation benefits are 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.

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.