Senior Specialist - CMC Data Steward - DSCS Digital

** Job Description*
* Digital is the multiplier that will allow DSCS to deliver better experiments faster, efficient filing and launch, more robust supply chains and higher-confidence decisions across the portfolio. The DSCS Digital Technologies organization is tasked with the mission to pioneer and deploy innovative digital technologies that drive the acquisition, automation and utilization of data to enhance insights, efficiency, and quality of DSCS processes and methods.

CMC Data Governance within DSCS Digital Technologies is seeking a Data Steward to implement our CMC data governance strategy.  The ideal candidate will possess expertise in design and execution of best governance practices to ensure data quality, compliance, and value realization across cross-functional digital initiatives.

** Responsibilities*
* + Own and maintain the quality, integrity, consistency, and governance of CMC data across systems.

+ Define, document, and ensure implementation of data standards, business rules, metadata, and controlled vocabularies for CMC processes and products.

+ Monitor data quality metrics, identify data issues, lead root-cause investigations, and coordinate corrective and preventive actions (CAPAs).

+ Partner with Manufacturing, R&D, Quality, Supply Chain, Regulatory, and IT teams to ensure data assets are appropriately governed for regulatory submissions and inspections, advanced analytics, machine learning, predictive modeling, and AI applications.

+ Drive master data management initiatives and support digital transformation, reporting, analytics, and AI use cases.

** Required experience*
* + Bachelor's degree in Life Sciences, Engineering, Data Management, Information Systems, Computer Science, or related field.

+ Demonstrated experience with data governance, data quality management, master data management, and/or stewardship programs.

+ Strong analytical, stakeholder management, and cross-functional collaboration skills, with the ability to translate business needs into data standards and governance practices.

** Preferred experience*
* +

Experience with enterprise systems such as SAP, LIMS, ELN, MES, Veeva, or similar platforms used in CMC operations.

+ 2+ years of experience in pharmaceutical, biotech, or life sciences environments with exposure to CMC, manufacturing, quality, or regulatory data.

*
* Required Skills:

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* Biodesign, Data Format, Data Governance, Data Modeling, Data Quality, Data Quality Assessments, Design Changes, Digital Transformation, Engineering Principle, Manufacturing Scale-Up, Master Data Management (MDM), Mechanical Systems Analysis, New Product Introduction (NPI), Preventive Action, Production Optimization, Stakeholder Management

** Preferred

Skills:

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* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** US and Puerto Rico Residents Only:*
* Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  ()  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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