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    Risk Based Quality Management Lead, Associate Director

    Beigene
    8+ years
    $140,600.00 - $190,600.00 annually
    Remote
    10 Aug. 14, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Risk Based Quality Management Lead

    Location: BeiGene, Global (Remote with occasional travel)

    Company Overview:

    BeiGene is rapidly expanding and offers exciting opportunities for experienced professionals who are motivated and collaborative. We seek individuals passionate about fighting cancer and advancing scientific and business excellence.

    Position Summary:

    The Risk Based Quality Management (RBQM) Lead is crucial in developing risk assessments for clinical development entities, monitoring quality signals, addressing issues, and enhancing the RBQM program. This role involves working closely with various stakeholders to ensure effective risk management and optimization of clinical development processes.

    Key Responsibilities:

    • Onboarding and Training:

      • Provide onboarding training and tools to support the adoption of RBQM within assigned teams.

    • Risk Management:

      • Facilitate risk management with stakeholders to identify critical quality factors and manage risks through evaluation, control, communication, and reporting.
      • Collaborate with Clinical Research Associates (CRAs), Central Statistical Monitors, Data Management, vendors, and other stakeholders to analyze risks and issues, propose follow-up actions, and ensure resolution.

    • Documentation and Reporting:

      • Draft, maintain, and archive risk management documentation, including risk/issue records, controls, findings, and resolutions, using RBQM tools and BeiGene SOPs.
      • Trend risks and issues across related entities and support optimization of controls based on risk evaluations.

    • Optimization and Support:

      • Assist study teams in optimizing RBQM models and serve as a change champion and subject matter expert.
      • Lead culture change and communication activities to support RBQM initiatives.

    • Ad Hoc Risk Assessments:

      • Conduct risk assessments as needed to support clinical development and business goals.

    Supervisory Responsibilities:

    • Influence across levels, functions, countries, and time zones.

    Required Qualifications:

    • Experience: 8+ years leading risk assessments in the pharmaceutical industry or a similar field. Prior experience in deploying risk-based quality management programs is preferred.
    • Skills:
      • Independent management and oversight capabilities.
      • Experience in cross-functional team communication.
      • Knowledge of clinical trial management, protocol understanding, and related documentation.
      • Strong analytical skills to interpret complex data and provide insights into risk reports.
      • Therapeutic area experience, particularly in Oncology/Hematology, is preferred.
      • Proficiency with relevant technology and risk-based tools/platforms.
      • Understanding of ICH guidelines and regulatory environments.
    • Education:
      • Bachelor’s degree in Business or Science-related field.
      • Master’s degree in Business or Science-related field.

    Competencies:

    • Fosters teamwork and collaboration.
    • Provides and solicits honest, actionable feedback.
    • Demonstrates self-awareness and inclusive behavior.
    • Shows initiative and an entrepreneurial mindset.
    • Commits to continuous learning and embraces change.
    • Results-oriented with strong analytical and data analysis skills.
    • Communicates clearly and maintains financial excellence.

    Salary Range: $140,600 - $190,600 annually. Compensation packages are based on factors including skills, experience, education, and location. Non-commercial roles are eligible for annual bonuses, while commercial roles participate in incentive plans. All employees can own BeiGene Ltd. stock through discretionary equity awards and the Employee Stock Purchase Plan. Benefits include Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.

    Equal Opportunity Statement:

    BeiGene is an equal opportunity employer and values diversity. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected status. Employment decisions are based on qualifications, merit, and business needs.

    Apply Now:

    Join us in our mission to transform cancer treatment and make a significant impact on patients' lives. Apply today to be part of our dynamic team.

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