
Site Data Governance Lead
2 weeks ago
Associate Director Site Data Integrity Lead
Our global biopharmaceutical manufacturer is seeking an experienced Associate Director Site Data Integrity Lead to oversee quality governance and lead implementation of data integrity and computer system validation processes.
Key Responsibilities:
- Oversee quality governance for electronic and computerized systems, such as MES, DeltaV, LIMS, ELN, and SAP.
- Lead the implementation of data integrity and CSV processes, ensuring compliance with global regulations.
- Manage the 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.
Requirements:
- Bachelor's or higher degree in Science, Engineering, Computer Science, or a related field.
- 10+ years of experience in quality/compliance within biopharma or biotech environments.
- Strong understanding of GMP, CSV (GAMP 5), and global data integrity regulations.
- Proficiency with lab and manufacturing systems, and validation tools.
- Excellent leadership, communication, and cross-functional collaboration skills.
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