• A primary point of contact for resourcing and guidance of product release team • Provide QTC review and approval of in-process tasks related to product and/or service provision • Develop and oversee onboarding and training of Analysts on QTC product release team • Act as subject matter expert and point of contact for Software Development Life Cycle process • Develop, write, and revise controlled Validation Deliverables and in continuous improvement efforts and procedures and practices related to product release • Provide ad hoc training to Operations staff on compliance procedures associated with product release • Responsible to perform the following QTC product release duties • Generate, perform review, and maintain records of Validation Deliverables documentation and ensure compliance to procedures and processes. • Maintain validation documentation in QMS according with company procedures • Provide support to operations staff to develop, write, and revise controlled Validation Deliverables. • Act as primary QTC representative and resource to Operations staff with regards to product release • Maintain validation documentation in QMS according with company procedures • Assist in preparation, review, and maintenance of reports for identified product events • Participate in Root Cause Analysis meetings with the Operational staff and provide input on the identification and documentation of Corrective Actions/ Preventive Actions for events of discrepancy or failure of released product • Assist CAPA team in completion of outstanding CAPA items with the appropriate stakeholders as it relates to product release. • Support the Governance unit in preparation for External Audits related to product release. • Perform QMS documentation Quality Control (QC) reviews on controlled documents such as SOPs, Work Instructions and Policies as well as provide feedback to key stakeholders as needed.