Sophia Nuijens

Experience

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  BOC Gases (The Linde Group)

  Jan 1995 - Jan 2002

  Continued forward progression to identify and implement process improvements to create a cohesive focus and ensure successful project execution within the Packaged Systems division supplying modular, pre-fabricated on-site oxygen and nitrogen supply systems. Project Manufacturing Engineer NJ ; Cost Control Engineer London, UK; Internal Auditor London, UK Manufacturing Systems Engineer London UK,

  • Program Manager, Applications Integrations Engineering

    Jan 2001 - Jan 2002

  • Project Engineer (Various)

    Jan 1995 - Jan 2002
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  Stryker

  Jan 2002 - Jan 2014

  Senior Manager of Global Program Solutions, UDI, 2013 – 2014Hand-picked to lead the company’s MDM response to the FDA’s mandate for a unique device identifier (UDI, readable/AutoID) for each product. Program spanned all products on a global scale across Reconstructive, Neurotech/Spine, and MedSurg businesses. Collaborated with IT on the design and launch of a global product data hub. Identified, vetted, and co-led the selection of a technology vendor (IBM) to provide a robust UDI solution. Secured approval of multimillion-dollar budget.Educated teams on the new regulatory requirements and championed Stryker’s data governance strategy worldwide. Show less Manager of Master Data System, Global IT, 2012 – 2013Selected as the Global Item Master lead for a cross-functional team (Shared Services, RA/QA, Supply Chain, Global IT, Finance, Legal, Regulatory) spearheading a wide range of strategic initiatives visible at the C-suite level.Partnered with functional stakeholders to create a governance structure/policies that drove integrity of master data assets.Owned the MDM IT thread to achieve compliance and cost avoidance following the introduction of a 3% medical device tax. Show less Manager of Data Quality, Orthopaedics Division, 2006 – 2012Promoted to own global data for the company’s largest division. Managed matrixed resources and project budgets.Worked with decision makers worldwide to design and rollout an item data governance framework on a global scale. This would become the model for all Stryker businesses.Oversaw the change control process, documentation control, and the development/implementation of new SOPs.Achieved 97% data quality accuracy rate in a business spanning 100+ countries. Show less

  • Senior Manager of Global Program Solutions, UDI

    Jan 2013 - Jan 2014

  • Manager of Master Data System, Global IT

    Jan 2012 - Jan 2013

  • Manager of Data Quality, Orthopaedics Division

    Jan 2006 - Jan 2012

  • Item Master Lead, ERP Implementation

    Jan 2004 - Jan 2006

  • Knee Instruments Cell - Production Planner/Technical Support

    Jan 2002 - Jan 2004
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  Celgene

  Jan 2014 - Jan 2019

  Associate Director of Global Supply Master Data, 2016 – 2019Promoted to serve as the Enterprise Governance Lead for all product data with impact on 10 marketed drug therapies, 500K+ patients, and 52+ active clinical programs. Built the team from 1 to 8 direct reports and a 200+-member global user community.Harnessed market insights and industry’s Identification of Medicinal Products (IDMP) standard in the design of a tech-enabled enterprise product domain initiative.Built the business case for the multiyear program; gained buy-in from senior R&D, operations, chemistry, manufacturing, controls, and IT stakeholders; secured budget resources; and led the global agenda across markets.Earned recognition as a strategic advisor to the C-suite; educated decision makers on short- and long-term vulnerabilities as well as opportunities to utilize master data to mitigate risk and uncover new channels of growth.Concurrently served as head of the Enterprise Data Governance Council. Panelist at the 2017 BSMA Conference. Show less Senior Manager of Global Supply Chain Master Data, 2014 – 2016Selected to transform and lead the master data management process for Celgene’s Global, Pharmaceutical Development & Operations division. Recruited and built a best-in-class team of 7 direct reports. Managed project budgets.Quickly evaluated the business, talent (1 team member), processes, systems, and regulatory requirements. Defined a new GxP-focused strategy, put sustainable SOPs/WPs in place to support company’s need for trusted BI on product data.Work was pivotal in supporting a large-scale ERP implementation and the company’s first-ever standardization across a global supply chain network representing internal manufacturing operations and contract manufacturers. Show less

  • Associate Director, Global Supply Master Data

    Jan 2016 - Jan 2019

  • Senior Manager Global Supply Chain Master Data

    Jan 2014 - Jan 2016
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  Bristol Myers Squibb

  Jan 2019 - now

  Global Master Data Governance Lead/Business Process Owner, Cell Therapy, Recruited to lead development of a global MDM strategy to support early-stage division’s clinical-to-commercialization trajectory.Quickly gained an in-depth understanding of business unit’s complex master data flow across multiple systems.Built and leverages collaborative relationships globally to create, launch, and scale MDM capabilities and programs across all domains. Harmonizes business growth objectives with adherence to data quality standards.Navigates team through ongoing change, including acquisitions (e.g., Juno Therapeutics, Bluebird Bio) and Celgene’s post-acquisition integration into the Bristol-Myers Squibb infrastructure.Owned MDM strategy during critical, fast-track ERP implementation; project was delivered on time and within budget.Mentors young professionals and inspired leaders. Leads team in a perpetual state of development and improvement. Show less

  • Director, Data Product - Drug Development Operations and Real-World Evidence.

    Sept 2023 - now

  • Director, Data Partner, Global Drug Development and Supply Chain

    Apr 2020 - Sept 2023

  • Global Master Data Governance Lead/Business Process Owner

    Jan 2019 - Apr 2020