Job type full-time
Full job description
SrManager, machine learning digital quality management system
Seeking a srManager, machine learning digital quality management systemThe role will require cross-functional interactions and collaborations across the enterpriseS/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
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 needsHe/she communicates issues, as necessary, to senior management and collaborates with clinicians and biostatisticians as neededThis includes communication and quality oversight of the vendorHe/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.
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
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
Job type: full-time