BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Product Quality Steward (PQS), as part of the Quality Sciences and Knowledge Management organization, will play a critical role in advancing global quality initiatives and manufacturing strategies ensuring the highest standards of product quality and fostering expertise in emerging quality technologies. This position will actively contribute to quality improvement through execution of core QMS product governance tools including change management, APQR and Issue Escalation/Notice to Management. The Product Steward will actively analyze product data trends such that proactive compliance is maintained for BeOne’s patients. The PQS will support cross-functional collaboration, drive process improvements and enhance the organization's approach to quality governance through the entire product lifecycle. Ensure comprehensive root cause analysis for investigations, OOS and other events drives effective CAPA plans . This individual will collaborate across functions and sites to drive continuous improvement, ensure regulatory compliance, and build a robust knowledge-sharing and risk management culture. Represent the Quality Organization at platform level through participation in molecule level governance meetings and forums. Serve as a Subject Matter Expert (SME) and Facilitator for quality risk assessment, investigations, change control, and resolution of complex quality issues including review of regulatory CMC submission content Manage Product Quality Network teams responsible for deliverables for multiple late-phase clinical or commercial programs Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management. Advise and influence CMC strategies leveraging quality risk management (ICHQ9) for commercialization including strategies for in process controls, specifications, stability, and comparability Contribute to product quality performance monitoring, identifying trends and driving improvements. Lead or participate in cross-functional teams to improve quality systems and address systemic challenges. Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices. Perform other related responsibilities as assigned. Supervisory
Responsibilities
5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
Education
Required: Bachelor’s degree and 6+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices). Master’s degree and 8+ years experience preferred Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Experience
in statistical modeling software (Mintab, JMP, Tableau, SciLab Other
Qualifications
Advanced degree in life sciences, quality management, or related field Extensive experience in leading quality investigations, quality risk management, and implementing new technologies. Expertise in quality systems, regulatory requirements (e.g., FDA, EMA), and risk management frameworks (e.g., ICH Q9). Strong leadership and problem-solving skills, with the ability to manage complexity and ambiguity.
Experience
in developing and delivering global training programs ad fostering SME networks. Proficiency in quality tools and methodologies (e.g., root cause analysis, Lean, Six Sigma). Ability to communicate complex information clearly and effectively across business functions Travel: Up to 20% Salary Range Switzerland: 148,900.00 CHF - 186,100.00 CHF Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit