Associate Director - Risk Based Quality Management Lead

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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.

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.
• Additional activities as needed to support business goals.

Supervisory Responsibilities:  

• Matrix influence across levels, functions, countries and time zones

Qualifications:

• Bachelors in Business or Science-related field, Masters in Business or Science-related field
• 5-10 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

Computer Skills: Windows, Offices, Analytics Tools

Travel:  0-20%

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 and we value diversity. 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.