Digital CMC Data Strategy Lead

3 weeks ago


Rahway, United States Insight Global Full time

Required Skills & Experience

  • Extensive experience in data strategy, digital transformation, data management in CMC strategy
  • Demonstrates exceptional cross-functional leadership by effectively communicating complex data concepts to diverse stakeholders
  • Hands-on experience with process and knowledge management systems, data sources/sourcing, and export systems. Proficient in LIMS, ELN, MES, ERP, SAP, DeltaV, and familiar with CRO/CMO sources.
  • Established track record of identification of data-related challenges, propose innovative solutions, and implement strategies to address them.
  • Understanding of the industry, market trends, customer needs, and business processes to develop data strategies that drive business value.


Nice to Have Skills & Experience

  • Experience in process or analytical development, characterization, technology transfer, validation, / PPQ., facility fit, risk assessments, manufacture campaigns, process and plant modeling, regulatory filings (IND, BLA, PAS)


Job Description

Working in partnership with IT and the digital CMC workstream leads to define and design the data strategy: data usage, identify the types and sources of data that will be collected.

Establish data governance policies, define data quality standards, and determine the technology infrastructure and tools needed to support the data strategy at a day-to-day level.

For the various workstreams surrounding process and analytical knowledge transfer along with regulatory authoring the lead will work to address: Efficiently identify, assess, acquire, and manage data to gain insights for strategic advantages in line with FAIR principles.

Define how we organize data to be analytics ready, support EA principles, and capture information from ongoing POCs to meet service target selection needs in the future state.

Lead integrated semantic layer that will serve as a common language that enables consistent interpretation and representation of data elements, their relationships, and their contextual meaning: establishing a logical and structured framework to bridge the gap between different data sources, systems, and formats.

Effectively communicate complex data concepts to various cross functional stakeholders, work collaboratively with cross-functional teams, and build consensus around data and systems initiatives, with an enterprise mindset.

Leading through influence to identify and address cross divisional situations and proactive risk identification and mitigations that are embedded within the workstreams and digital CMC (as it faces the enterprise)



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