Quality Control Project Lead — Roche

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 We are seeking a highly motivated and experienced Quality Control Project Lead (QC-PL) to oversee and coordinate GMP analytics in QC IMP for synthetic molecules (PTDC-A QC-IMP). Our department is responsible for testing direct materials, Active Pharmaceutical Ingredients (APIs), and drug products, conducted both internally and externally at Contract Manufacturing Organizations (CMOs). Our team of skilled associates and scientists manages critical analytical tasks, including stability studies, validations, and method transfers. The Opportunity • Project Management: Lead and oversee analytical projects, ensuring strict adherence to GMP regulations, timelines, and quality standards. • Stability Study Coordination: Coordinate comprehensive internal and external (CMO) stability studies for synthetic molecules, APIs, and drug products. • Analytical Oversight: Ensure all testing is conducted according to regulatory guidelines, maintaining the highest standards of data integrity. • Data Review and Reporting: Review analytical data for precision, accuracy, and completeness. • Vendor Management: Collaborate with CMOs to ensure efficient communication, project execution, and compliance for all stability studies. • GMP Compliance: Ensure all stability activities strictly adhere to internal SOPs, GMP standards, and relevant regulatory requirements. • Problem-Solving: Proactively address and resolve issues related to stability studies, including troubleshooting analytical methods and managing deviations. • Cross-Fu