Risk Based Quality Management Lead
Vor 7 Tagen
We are seeking a highly skilled Risk Based Quality Management Lead to join our team at BeiGene. As a key member of our clinical development team, you will be responsible for creating risk assessments, following up on quality signals, and contributing to the advancement of our RBQM program.
About BeiGeneBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and passionate about fighting cancer.
Key Responsibilities- Risk Management: Facilitate risk management with stakeholders to identify critical to quality factors, and identification, evaluation, control, communication, review, and reporting of risks.
- Team Collaboration: Collaborate with CRAs, Central Statistical Monitors, Data Management, vendors, process owners, and others as needed to analyze risks and issues using quality performance data.
- Documentation: Draft, maintain, and archive documentation of risk management activities, including risk/issue(s), controls, findings, escalations, tracking, and resolution utilizing RBQM tools and following BeiGene SOPs.
- Trending Risks: Trend risks and issues across related entities.
- Control Optimization: Support the study team in optimizing controls applied based on risk evaluation.
- Culture Change: Develop and lead culture change and communication activities with stakeholders.
- Bachelor's degree in Business or Science-related field; Master's degree preferred.
- 5-10 years leading risk assessments in the pharmaceutical industry or equivalent experience.
- Prior experience deploying risk-based quality management programs across clinical development is a plus.
- Ability to work independently and collaboratively within cross-functional teams.
- Knowledge of overall clinical trial management process, understanding of protocols, and other clinical trial-related plans and documents.
- Estimated Salary: $120,000 - $150,000 per annum.
- 0-20% travel requirement.
- Opportunity to work with a global team environment.
- 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.
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