Lead Data Integrity Director
* Oversight and governance of quality processes for electronic and computerized systems.
* Implementation of data integrity and CSV best practices.
* Management of the validation lifecycle, change control, deviations, and CAPAs.
* Support for regulatory inspections and maintenance of inspection readiness.
* Driving continuous improvement and contributing to global quality strategies.
* Training and mentoring staff in data integrity and CSV principles.
Requirements:
* A degree in Science, Engineering, Computer Science, or a related field.
* Minimum 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 collaboration skills.