United States onlyBeiGene 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 Risk Based Quality Management Lead will create risk assessments for any entity 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
Supervisory Responsibilities:
- Matrix influence across levels, functions, countries and time zones
Computer Skills: Windows, Offices, Analytics Tools
Other Qualifications:
- 8+ years leading risk assessments in the pharmaceutical industry or equivalent
- 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%
Education Required:
Bachelors in Business or Science-related field
Masters in Business or Science-related field
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 fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.
