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Remote - Senior Manager, Machine Learning Digital Quality Management System, Emeryville, California

CountryUnited States
Job Description

Sr. Manager, Machine Learning Digital Quality Management System

Seeking a Sr. Manager, Machine Learning Digital Quality Management System. The role will require cross-functional interactions and collaborations across the enterprise. S/He will act as a key advisor and influencer and be required to both establish and apply new ML methods to specific problem domains within various functions.
  • Quality lead for key ML pilots to ensure successful completion and develop plans to integrate capabilities into the normal early clinical development process
  • Influence, from quality perspective, the development of BGNE's overall ML objectives and long-range goals
  • Through Artificial Intelligence/ML, identify risks before they occur and enable Quality Assurance to achieve continuous improvements

Main Purpose:

  • Ensure any Data Science and Machine Learning (ML) used within BeiGene are following applicable GXP regulations
  • To advance the utilization of ML to unlock actionable insights from data to provide efficient solutions to the Quality, Compliance, Audit, Learning & Performance functions, and broader R&D stakeholders
  • Application of deep learning methods to problems and support in clinical studies as well as early discovery and research, adverse event prediction
  • Ensure data access, application of appropriate analysis methods to unlock information and meaningful visualization and interpretation of information to derive actionable insights
  • Develop and support ML and Business Intelligence solutions


  • Responsible for serving as a liaison with the Data, internal and external data partners, monitoring and meeting agreed upon project(s) milestones, escalating issues as needed to appropriate Data vendor and estimating resources needs. He/She communicates issues, as necessary, to senior management and collaborates with clinicians and biostatisticians as needed. This includes communication and quality oversight of the vendor. He/She has diverse problem-solving skill and is comfortable representing the analytical programming perspective to the Project Team and is often the sole functional representative
  • Development of new and novel Deep learning methods for reinforcement, learning, knowledge transfer and generative methods
  • Develop the software tools and library for application of deep learning methods, and train other colleagues within BGNE to develop and use the tools in their applications
  • Possess in-depth knowledge of multiple real-world data assets and share information about these data to business partners and the IT team.
  • Provides guidance and support to business and quality system process owners through accessing, analyzing and visualizing data relevant to their process or network to identify weak signals and improvement opportunities.
  • Participates on cross functional teams, projects and/or programs with the goal of systematically integrating data, deriving insights and automating processes.
  • Partner across the entire value chain at BGNE R&D to commercial manufacturing to interact and learn from teams involved in business process execution, automation tools, and data generation while ensuring applicable regulations adherence.
  • Successfully executing projects allowing for identification of insights and improvement opportunities as well as ultimately deriving substantial business value from operational data.

Supervisory Responsibilities:

  • Ensures the competencies and skills required for the ML team is consistent with the company defined requirements.
  • Mentor team members to support development by delegating responsibilities, overseeing and supporting development plans.
  • Conduct quarterly check-ins and year end performance appraisals for direct reports which includes providing ongoing and constructive feedback.

  • Master's degree in data science or related field
  • OR Bachelor's degree and 2 years of applied data science experience in industry
  • OR Associate degree and 4 years of applied data science experience in industry
  • OR High school diploma / GED and 6 years of applied data science experience in industry
  • Knowledge of GxP concepts and guidelines
  • Experience with document control activities required
  • Experience with QMS or other advanced document control system required
  • Requires strong written, oral, interpersonal and communication skills
  • Demonstrated ability to perform detail-oriented work with a high degree of accuracy and completeness

Computer Skills:
  • Strong technical and application development background
  • Strong organization skills and attention to detail
  • Understanding of QMS best practices, including familiarity with regulatory requirements related to vendor management, audit management, and record keeping.
  • Experience authoring QMS procedures and streamlining process.
  • Experience implementing and/or serving as business lead for QMS / document control systems desired.
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

  • Travel: As required
EmployerACS Group