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. General Description: The QMS Business Process Owner (BPO) for Risk & Knowledge Management is responsible for oversight of BeOne’s Quality Risk Management (QRM) framework, including procedures and tools which ensure compliance with regulatory requirements (e.g., ICH Q9). As BPO, the Director will train others and serve as Facilitator for quality risk assessment as part of investigations, change control, or during resolution of complex quality issues or as Subject Matter Expert (SME) during Health Authority Inspections. Further, as part of the Quality Sciences Product Data Quality function, this position will advance knowledge management processes using best practices (e.g., ICH Q10) and Data Integrity principles to enable rapid access to BeOne’s product data and process knowledge through the entire product lifecycle. The BPO will collaborate to build processes and drive behaviors which assure Data Integrity within BeOne’s compliance controls such as dossier check, combination drug product master file and other GMP archival programs. This role requires a blend of technical expertise, leadership skills, and a proactive approach to quality and risk management as well as to continuous improvement.
Essential Functions
of the Job: Cross-Functional Collaboration: Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders for implementation of standards, policies, and procedures supporting Product Data Quality. Plan and guide interactive risk sessions using formal and informal methods like FMEA, FTA, Risk Ranking or SWOT analysis. Regulatory and GxP Compliance: Ensure that the BeOne’s risk based decisions and position(s) are well prepared and documented to meet relevant regulatory agency and other relevant requirements for the industry (FDA, EMA, local regulations, ISO, WHO); prepare for and support inspections and audits. Training & Communication: Identify opportunities to improve data-related processes, systems and tools within all GMP business areas that are aligned with BeOne’s evolving needs and industry standard processes Metrics & Reporting: Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports. Supervisory
Responsibilities
6 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 8+ 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 10+ years direct experience preferred Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc) Other
Qualifications
Experience
with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics. Travel: Up to 20% Salary Range Switzerland: 178,600.00 CHF - 223,300.00 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