The Sr Specialist QA IT Systems is responsible for providing direction in quality assurance software validation activities including: reviewing software requirement documents; writing and reviewing validation documents; executing and reviewing validation test cases; and updating departmental procedures. This position ensures that defined software validation practices and procedures are being followed.

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.