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