This role enhances worldwide access to biotherapeutics by ensuring the integrity, compliance, and validation of critical computerized systems supporting our biologics manufacturing operations. The Senior Manager will establish and maintain validation and data integrity programs for all GxP computerized systems. This position is responsible for developing and implementing policies and strategies that ensure compliance with regulations, and provides leadership in computerized systems validation and data governance.

This role offers a significant opportunity to improve worldwide access to biotherapeutics by ensuring the integrity, compliance, and validation of critical computerized systems supporting our biologics manufacturing operations. The Senior Manager will establish and maintain comprehensive validation and data integrity programs for all GxP computerized systems within our manufacturing network.

Seeking an experienced Validation Tester to support a 1-month contract through the end of June 2025 (potential for extension) with the State of MaineBureau of General Services. The role involves co-developing and executing test cases, maintaining comprehensive test documentation, and validating the testing completed by the vendor. This position will be responsible for collaborating with the project team to complete the testing processes.