Develop/execute strategies and procedures for software (SW) validation. Manage the Software Lifecycle program. Job duties:Develop strategies for continuous improvement to the SW lifecycle program to ensure improved compliance to regulations (e.g., identify which procedures are required, high level summary of the required sequence of events, etc.). Develop SW validation procedure(s) as needed to ensure alignment with appropriate regulatory requirements, including, but not limited to, SOPs, forms, SW categorization procedures, risk assessment procedures, change control documents, etc. Manage completion of projects per SW validation master plans and ensure timely completion. Maintain frequent communication with stakeholders and manager regarding project status. Derive solutions to challenges and escalate any issues as they are identified. Work with software owners to generate and maintain master SW list(s). Provide expertise to SW owners with regards to identifying required level of validation for SW items. Review and approve SW validation protocols and reports (verify test cases are adequate, verify executed protocols for GDP, etc.). Ensure software lifecycle program complies with applicable regulatory requirements including requirements for electronic records and electronic signatures. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. Perform additional duties as assigned.