Senior Manager Risk Based Quality Management

vor 2 Wochen

Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

Risk-Based Quality Management Lead Job Description

At BeiGene, we are committed to delivering high-quality medicines to our patients. To achieve this goal, we are seeking a highly motivated and experienced Risk-Based Quality Management Lead to join our Clinical Development team.

Job Summary:

The Risk-Based Quality Management Lead will be responsible for creating risk assessments for entities in clinical development, following up on quality signals, issues, and open actions, and contributing to the advancement of the RBQM program.

Main Responsibilities:

  • Provide assigned teams with onboarding training and tools to aid in the adoption of RBQM.
  • Facilitate risk management with relevant stakeholders for the identification of critical-to-quality factors, and identification, evaluation, control, communication, review, and reporting of risks.
  • Collaborate with CRAs, Central Statistical Monitors, Data Management, vendors, process owners, and others as needed to analyze risks and issues using quality performance data, identify follow-up actions, and oversee the completion of identified actions.
  • Draft, maintain, and archive the documentation of risk management activities, such as risk/issue(s), controls, findings, escalations, tracking, and resolution, utilizing RBQM tools and following BeiGene SOPs.
  • Trend risks and issues across related entities.
  • Support the study team and other contributors to clinical development in the optimization of controls applied based on risk evaluation, for example, optimizing the application of source data verification and source document review.
  • Support the study team in optimizing the RBQM model, including acting as a change champion and subject matter expert for a risk-based environment.
  • Develop and lead culture change and communication activities with stakeholders.
  • Conduct 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:

  • Bachelor's in Business or Science-related field, Master's 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 a global team environment.

Computer Skills: Windows, Offices, Analytics Tools

Travel: 0-20%

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

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