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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.
At Roche, we believe that every patient deserves access to life-changing innovations. As a global healthcare leader operating across pharmaceuticals and diagnostics, we combine cutting-edge science, advanced technology, and a passion for improving lives to address some of the world’s most challenging medical needs. Driven by our commitment to research and sustainable healthcare solutions, we foster an inclusive, collaborative environment where diverse teams are empowered to question the status quo, drive continuous improvement, and redefine what is possible in modern medicine.
The Pharma Technical (PT) Operations Global MSAT & Engineering group takes bold steps to modernize technical operations to enable Roche to deliver medicines for patients more quickly, efficiently and reliably. PTT shapes and accelerates technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today.
As the Principal Expert, you will act as the technical authority and global strategist for Direct Materials Certification and Filing. This position provides high-level technical oversight, proactively implementing enterprise-wide solutions for complex problems and ensuring global compliance with the most stringent Health Authority regulations. The Principal Expert drives the modernization of materials across the entire PT network, ensuring a robust and flexible supply chain from a compliance perspective to support Product Health across the product life cycle.
The Opportunity
Global Governance: Accountable and responsible for the global design and strategic execution of Certification & Filing business processes, ensuring standardization across Biologics, Synthetic Molecules and Cell & Gene Therapy area.
Strategy Development: Leads the development of enterprise-level Direct Materials Certification & Filing Strategies, serving as the primary bridge for Regulatory global compliance and Health Authority requirements ensuring simplification and alignment of approaches.
Stakeholders Influence: Drives modernization and technology innovation by influencing stakeholders (including senior stakeholders) to drive successful program implementation.
Complex Problem Solving: Applies data-driven knowledge to the complex regulatory challenges, particularly in high-risk areas such as virus-risk, BSE/TSE, and biological-derived material compliance.
Expert Review: Serves as the final reviewer and approver for enterprise-wide compliance, technical, and scientific documents, holding legalization signature authority for Roche products.
Compliance Leadership: Maintains a state of global inspection readiness at all times and spearheads the implementation of major compendia changes or responses to Health Authority audits.
Strategic Alignment: Accountable for building high-level collaborations and work relationships between key stakeholders including External Quality, Procurement, Quality, Manufacturing, and Regulatory.
Who you are
Experience & Education: BS/MS/PhD in Science, Engineering or Management with at least 8 years of experience in the pharmaceutical, pharmaceutical or medical device industry including extensive experience in regulatory filings and material specifications is beneficial
Strategic Leadership: Proven ability to combine strategic clarity with innovative thinking, aligning with matrix leadership model and coaching capabilities.
Expertise: Expert-level knowledge of international standards (ICH, ISO), Pharma GMP operations, and Health Authority regulations.
Advanced knowledge of Operational Excellence tools e.g., statistical methods, FMEA, Six Sigma, Lean Principles.
E2E Thinking: Proven experience working in and leading high-impact teams in a global matrix setting.
Outstanding Communicator and Influencer: Exceptional ability to build connections, influence business needs, and foster a collaborative environment across the enterprise.
Inclusive and Open Minded: Committed to creating an inclusive environment where team members feel safe, valued, and empowered to perform their best.
Relocation benefits are not available for this posting
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 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.
Roche is an Equal Opportunity Employer.
