Job title: Quality Management System Analytics Manager
Location : Remote (7 Month contract with extension possibilities)
Position Summary
The manager / Senior Manager (M/SM), Quality Management System (QMS) Analytics is responsible for developing novel approaches to understand various types of data including but not limited to Quality Systems data (e.g. Deviations, CAPAs), operational data as part of the manufacturing lifecycle, and financial data (e.g. capital and operational expenses) using analytics and advanced modeling techniques. In addition, the current role is expected to interact with key stakeholders (e.g. GxP subject matter experts (SMEs), business process owners (CPOs) and Quality Business Partners, etc.) to help design leading quality KPIs to enable enhanced performance. Importantly, this role will also support development and implementation of quality data analytics automation to maximize efficiency in metrics reporting and data visualization.
Principal Responsibilities
- Provide support inQMS dataanalytics and advancedprograming to the Associate Director of QualityAnalytics team and / or project stakeholders within and beyond the Central Quality System and Compliance (CQSC), which includes:
- Appropriately framing questions to be answered / issues facing the organization
- Choosing an analytical methodology that is situationally appropriate
- Understanding data correlations across databases and developing data mapping strategies for standardization
- Applying data cleansing and data QC techniques to leverage data integrity
- Utilizing advanced programing/coding to automate analysis pipelines
- Visualize results / data with experience in tools such as R-Shiny, Power-BI, Tableau, Qlik Sense or equivalent
- Interrogating data with in-depth analyses and extracting right information to support metrics reporting
- Developing appropriate analysis models (including machine learning and / or artificial intelligence (AI) as appropriate) to conduct analysis, interpret results and determine potential risks, time impact, costs, and value
- Present and explain analysis and options
- Work with various stakeholders (e.g. quality process owners) to derive leading KPIs to drive performance
- Support ad-hoc data query requests
- Develop predictive / forecasting dashboards to support Management Reviews
- Support development of the data strategy for Quality
- Evaluate and help select analytics tools and / or platform and support development of user requirements, system specifications and validation testing scripts (as needed)
Qualifications
- At least 2 years of data science / analytics or related field experience, experience working in a pharmaceutical / life science company preferred
- Prior knowledge in Quality & Compliance and/or existing experiences in understanding quality management system (QMS) components considered a big plus
- Understanding of industry trends in analytics, database technologies, machine learning, and statistical analysis
- Comprehensive understanding and use of experience with quantitative principles, concepts, practices, and standards
- Advanced data modeling and programing capabilities and knowledge of coding techniques in R, Python or SAS, etc. and advanced Excel skills
- Capability and/or potentials (e.g. through training courses) to develop / apply machine learning and artificial intelligence concepts
- Ability to present data, ideas, and rationale clearly to a broad audience and strong communication skills
Education
- BS with education/training from a strong analytical field such as statistics/biostatistics, information science, applied mathematics, quantitative engineering or computer science
- Masters degree or above in Data Science / Analytics or equivalent preferred