
Data Governance Specialist
4 days ago
Job Opportunity
\The role of Associate Director Site Data Integrity Lead involves overseeing quality governance for electronic and computerized systems, leading implementation of data integrity and CSV processes, and managing validation lifecycle.
\Key Responsibilities:
\- \
- Oversee quality governance for electronic and computerized systems (e.g., MES, DeltaV, LIMS, ELN, SAP)\
- Lead implementation of data integrity and CSV processes\
- Manage validation lifecycle, change control, deviations, and CAPAs\
- Support regulatory inspections and maintain inspection readiness\
- Drive continuous improvement and contribute to global quality strategies\
- Train and mentor staff in data integrity and CSV best practices\
- Ensure compliance with GMP, CSV (GAMP 5), and global data integrity regulations (e.g., 21 CFR Part 11, Annex 11)\
- Collaborate with cross-functional teams to achieve organizational objectives\
- Develop and implement policies and procedures to ensure data accuracy and integrity\
- Monitor and analyze data to identify trends and areas for improvement\
- Communicate effectively with stakeholders to facilitate data-driven decision making\
- Stay up-to-date with industry regulations and developments to ensure the organization remains compliant and competitive\
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