Full Job Description
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
This position reports directly to the Governance and Performance Management (GPM) and External Engagement Lead, and is responsible for working with other GPM Integrators collaboratively across the GxPs to establish and monitor quality and compliance leading and lagging indicators across the product lifecycle. The incumbent will analyze quality performance data to proactively identify emerging trends, and ensure the appropriate review and analysis of performance and risk are occurring at the right levels of the organization as part of the enterprise-wide Quality Council tier program.
Major Duties and Responsibilities
The Governance and Performance Management Integrator should apply strong project management, data analysis, and data structuring to accomplish the following duties and responsibilities:
Execute activities associated with the GxP Governance and Performance Management program with respect to data analysis, trending and visualization.
Perform data collection, analysis, review, and reporting of accurate and on time monthly metrics that support the tier governance Quality Councils.
Assist in the deployment of new strategies that deliver a robust metric collection process, foster a continuous improvement mindset, and build in capability for functional GxPs across the greater enterprise.
Ownership of critical business tools (e.g.; SharePoint, GMAC, Tableau, SpotFire, and other automation tools), which includes maintenance, troubleshooting, and training .
Provide direction and critical input in setting, monitoring, and analyzing key performance indicators across the QMS for Tier 2 Quality Councils, and ensure alignment with applicable Tier 3 Quality Councils.
Work horizontally across Tier 2s to analyze and integrate metrics data across GxPs for review at Tier 1 Quality Council with appropriate risk mitigation strategies centered around health of the QMS, products in development and in commercial supply.
Seek opportunities for improvement, simplification and efficiency across the GxP Quality Performance Management landscape.
Develop tools that provide efficiency in interpreting data sets to ensure identification of emerging challenges at the GxP and enterprise level.
Transform analysis of data into appropriate outputs with insights that can be easily interpreted for short term and long term business opportunities.
Partner with Business Insights and Analytics (BI&A) and IT to develop and implement improved mechanisms for metrics monitoring, analysis and reporting with cutting edge data analytics and technology solutions
Support BMS position on FDA Quality Metric program through current industry forums, establishing an internal process, data collection/analysis, and reporting within BMS and externally to FDA.
Contribute to the annual assessment of quality metrics for effectiveness and to improve the ability to make informed business decisions across the network.
Access key business systems to enable adhoc data analysis and to support greater designs of automation.
Develop as an SME (for Global Quality) on project Infinity (QMS) process flows and outputs to support the transition of data from in system to the active data lake for analysis, visuals, and automation efforts.
B.S. or B.A.
Master or advanced degree preferred
Minimum of 8-10 years of experience in the biopharmaceutical Industry in a Manufacturing, Quality, Technical, or Regulatory position or a combination thereof and/or working with a regulatory health authority.
Demonstrated knowledge of business analytics.
Experience interpreting customer analytical information requirements.
Experience solving complex problems through innovative analytical solutions and driving results.
Experience interpreting analytical results and ascertaining implications to the business.
Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
Pragmatic in approach with demonstrated ability to make sound, risk-based decisions.
Experience with Spotfire analysis platform, Tableau data visualization software, and similar plaforms/tools for data analytics and visualization.
OPEX/Lean Six Sigma experience preferred.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.