Global MSAT Scientific Expert

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 PositionA 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.The Global MSAT Scientific Expert (Validation Master Data Manager and User Support) is a vital member of our Global MSAT & Engineering team (PTT) responsible for maintaining and updating the master data in a centralized paperless validation system at Roche and to provide critical user support within the Roche network.  This role involves managing templates and ensuring standardization in our validation system, as well as handling data migration tasks, process change requests, and ensuring accurate record-keeping. This position requires a strong understanding of the Qualification and Validation business processes, an innovative and problem solving mindset along with a strong ability to work collaboratively with interfaces to Global and Local MSAT, Engineering, Quality and IT organizations. The Opportunity:You will develop and implement sustainable validation system strategies globally to ensure cGMP compliance.You will build, revise, and optimize Qualification/Validation business processes to align with industry best practices.You will perform risk assessments to identify and mitigate potential system compliance and quality issues.You will maintain accurate and organized system validation documentation, ensuring regulatory compliance.You will collaborate with cross-functional teams (Quality, Manufacturing, Engineering) for successful validation and qualification activities.You will act as a thought partner and presenter to senior management and stakeholders, building strong enterprise-wide relationships.You will lead change management for validation systems adoption across manufacturing facilities, including training, guidance, and continuous regulatory updateWho you are:You will bring 3-5 years of experience in the pharmaceutical or biotechnology industry, with a background in process development, operations/manufacturing, or related fields.You will demonstrate comprehensive knowledge of drug development, commercialization, supply chain, pharmaceutical quality systems, and global regulatory requirements (FDA CFRs, EMA, ICH).You will exhibit proficiency in validation methodologies, risk assessments, associated documentation, and familiarity with Valgenesis Validation Lifecycle Management System.You will resolve complex project documentation issues across business requirements, validation protocols, and technical support.You will effectively collaborate with internal and external partners and act as a coach and mentor, influencing colleagues and fostering decision-making.You will proactively foresee and solve problems, identifying opportunities and implementing solutions, while managing multiple priorities independently.You will leverage excellent communication and presentation skills to synthesize complex issues and effectively influence stakeholders at all levels. Travel Requirements:Anticipated domestic and international travel: