Specialist - CMC Data Steward

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., * 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.

• 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: 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

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.