Lead Data Integrity and CSV Professional Job Summary
We are seeking a highly skilled Associate Director to lead our quality governance for electronic and computerized systems. This role involves overseeing data integrity and computer system validation processes, managing the validation lifecycle, change control, deviations, and CAPAs.
The ideal candidate will have a Bachelor's degree or higher in Science, Engineering, Computer Science, or a related field, with at least 10 years of experience in quality/compliance within biopharma or biotech environments.
* Develop and implement strategies for quality governance across electronic and computerized systems.
* Manage the validation lifecycle, including planning, execution, and reporting.
* Ensure compliance with regulatory requirements through effective change control, deviation management, and CAPA implementation.
* Support inspection readiness by ensuring accurate documentation and maintaining up-to-date records.
* Drive continuous improvement initiatives and contribute to global quality strategies.