About us
BeiGene 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 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).
BeiGene 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.
Job Description:
General Description:
The Risk Based Quality Management Lead will create risk assessments for any entity (study, process, vendor, etc.) in clinical development, follow up on quality signals, issues and open actions and contribute to the advancement of the RBQM program.
Essential Functions of the Job:
- Provides assigned teams with onboarding training and tools to aid in the adoption of RBQM
- Facilitates risk management with the relevant stakeholders for identification of critical to quality factors, and identification, evaluation, control, communication, review and reporting of risks
- Collaborates with CRAs, Central Statistical Monitors, Data Management, vendors, process owners and others as needed to analyze risks and issues using quality performance data, to identify follow up actions and to oversee completion of identified actions
- Drafts, maintains, and archives the documentation of risk management activities e.g., risk/issue(s), controls, findings, escalations, tracking and resolution utilizing RBQM tools and following BeiGene SOPs
- Trends risks and issues across related entities
- Supports the study team and other contributors to clinical development in optimization of controls applied based on risk evaluation. For example, optimizing the application of source data verification and source document review.
- Supports the study team in optimizing the RBQM model including acting as a change champion and subject matter expert for a risk-based environment
- Develops and leads culture change and communication activities with stakeholders
- Conducts ad hoc risk assessments as needed to support clinical development
- Continued support of business goals
Qualification Required:
Supervisory Responsibilities:
- Matrix influence across levels, functions, countries and time zones
Computer Skills: Windows, Offices, Analytics Tools
Other Qualifications:
- Experience leading risk assessments in the pharmaceutical industry
- Prior experience deploying risk-based quality management programs across clinical development preferred
- Ability to work independently to complete management and oversight activities
- Experience working and communicating within cross-functional teams
- Knowledge of overall clinical trial management process, understanding of the protocol and other clinical trial related plans and documents
- Critical thinking and analytical skills to understand and analyze complex data and provide insight into risk reports, trends, and outliers in data
- Therapeutic area specific experience and knowledge – Oncology/Hematology preferred
- Ability to use the relevant technology and risk-based tools/platforms effectively
- Proven track record in delivering agreed results against a plan and timeline
- Understanding of ICH and regulatory environment
- Problem-solving skills
- Self-management skills
- Ability to work in global team environment
Travel: 0-20%
What We Offer To Our Valued Employees
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan!)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving!
- Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
- Join us and Make momentum in your career!
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeiGene’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.
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
