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.

• 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.

• 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.

• CAPA Management
• CMC Strategy
• Cross-Functional Collaboration
• Data Governance
• Data Lifecycle
• Data Quality
• Data Standardization
• Data Stewardship
• Digital Transformation
• Regulatory Compliance
• Root Cause Analysis (RCA)
• Stakeholder Management
• Systems Thinking

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

The salary range for this role is $ - $

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements,…