Remote Sr Manager, Machine Learning Digital Quality Mgmt System

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Posted 5 days ago United States Salary undisclosed
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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




Responsibilities:



  • 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 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.




Qualifications:



  • 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

- provided by Dice