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.
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
Advise and influence CMC strategies leveraging quality risk management (ICHQ9) for commercialization including strategies for in process controls, specifications, stability, and comparability
Supervisory Responsibilities:
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).
Expertise in quality systems, regulatory requirements (e.g., FDA, EMA), and risk management frameworks (e.g., ICH Q9).
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.
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Fosters Teamwork
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Provides and Solicits Honest and Actionable Feedback
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Self-Awareness
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Acts Inclusively
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Demonstrates Initiative
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Entrepreneurial Mindset
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Continuous Learning
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Embraces Change
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Results-Oriented
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Analytical Thinking/Data Analysis
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Financial Excellence
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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.
