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.
Skills Required
- Bachelor's degree and 6+ years experience in quality sciences, quality systems, or related regulated industry
- 5 years of managerial experience managing people or leading teams/projects/resources
- Expertise in quality systems, regulatory requirements (FDA, EMA), and risk management frameworks (e.g., ICH Q9)
- Extensive experience leading quality investigations, root cause analysis, OOS investigations, and implementing CAPA
- Proficiency with PC and MS Office (Outlook, Word, Excel, PowerPoint)
- Experience with statistical modeling software (Mintab, JMP, Tableau, SciLab)
- Proficiency in quality tools and methodologies (root cause analysis, Lean, Six Sigma)
- Strong leadership, problem-solving, and cross-functional communication skills
- Master's degree and 8+ years experience
- Experience developing and delivering global training programs and fostering SME networks
- Ability to advise on CMC strategies including in-process controls, specifications, stability, and comparability
BeiGene Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BeiGene and has not been reviewed or approved by BeiGene.
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Equity Value & Accessibility — Equity grants and stock programs are widely available across roles, including RSU grants at hire and opportunities to participate in company equity plans. Total compensation commonly includes equity alongside base pay and incentives.
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Healthcare Strength — Health coverage is described as comprehensive and high quality, with multiple mentions of “top notch” medical benefits. This strength is consistently highlighted as a key component of the package.
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Retirement Support — Retirement offerings include a 401(k) with a competitive employer match. These features contribute to a strong overall compensation bundle.
BeiGene Insights
What We Do
BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more 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 8,500 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal. See our community guidelines: bit.ly/39o3O6j
