What are the responsibilities and job description for the Risk Based Quality Management Lead, Associate Director position at BeiGene?
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
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
