Associate Director Site Data Integrity Lead
The Associate Director Site Data Integrity Lead will oversee quality governance for electronic and computerized systems, lead implementation of data integrity and CSV processes, manage validation lifecycle, change control, deviations, and CAPAs, support regulatory inspections, drive continuous improvement, and contribute to global quality strategies.
Key Responsibilities:
* Quality Governance: Oversee the quality governance for electronic and computerized systems (e.g., MES, DeltaV, LIMS, ELN, SAP)
* Data Integrity: Lead the implementation of data integrity and CSV processes
* Validation Lifecycle Management: Manage the validation lifecycle, change control, deviations, and CAPAs
* Regulatory Compliance: Support regulatory inspections and maintain inspection readiness
* Continuous Improvement: Drive continuous improvement and contribute to global quality strategies
* Training and Mentorship: Train and mentor staff in data integrity and CSV best practices
Requirements:
* Education: Bachelor's or higher in Science, Engineering, Computer Science, or related field
* Experience: 10+ years of experience in quality/compliance within biopharma or biotech environments
* Knowledge: Strong understanding of GMP, CSV (GAMP 5), and global data integrity regulations (e.g., 21 CFR Part 11, Annex 11)
* Skills: Proficiency with lab and manufacturing systems, and validation tools; excellent leadership, communication, and cross-functional collaboration skills