Jobgether
Director, It Validation
This position is posted by Jobgether on behalf of Dyne Therapeutics. We are currently looking for a Director, IT Validation in Waltham, MA. Step into a key leadership role ensuring that IT systems across a fast-growing biotech organization remain compliant, secure, and audit-ready. As Director of IT Validation, you'll be responsible for building and executing robust validation strategies for GxP-regulated systems and guiding cross-functional teams through a complex regulatory landscape. You'll act as a trusted advisor and subject matter expert, working hands-on with stakeholders to align technology operations with FDA, EMA, SOX, and other global compliance requirements. This is an onsite position offering direct impact, high visibility, and leadership opportunity in a dynamic, science-driven environment. Accountabilities: Develop and lead IT validation strategies ensuring alignment with 21 CFR Part 11, GAMP 5, and other applicable regulations for GxP systems. Oversee documentation lifecycle including validation plans, protocols (IQ/OQ/PQ), risk assessments, and traceability matrices. Maintain validated states across system lifecyclescovering implementation, upgrades, patches, and decommissioning. Collaborate closely with Quality, Regulatory, IT Security, and Operations to meet business and compliance needs. Act as subject matter expert, advising and training internal teams on validation best practices. Lead internal/external audits and manage responses and corrective actions related to IT compliance. Supervise, mentor, and grow a team of validation engineers and specialists. Manage validation efforts for cloud-based systems and platforms (especially AWS) and ensure vendor compliance. Stay current with industry trends, regulatory changes, and drive continuous improvement across validation processes.
This position is posted by Jobgether on behalf of Dyne Therapeutics. We are currently looking for a Director, IT Validation in Waltham, MA. Step into a key leadership role ensuring that IT systems across a fast-growing biotech organization remain compliant, secure, and audit-ready. As Director of IT Validation, you'll be responsible for building and executing robust validation strategies for GxP-regulated systems and guiding cross-functional teams through a complex regulatory landscape. You'll act as a trusted advisor and subject matter expert, working hands-on with stakeholders to align technology operations with FDA, EMA, SOX, and other global compliance requirements. This is an onsite position offering direct impact, high visibility, and leadership opportunity in a dynamic, science-driven environment. Accountabilities: Develop and lead IT validation strategies ensuring alignment with 21 CFR Part 11, GAMP 5, and other applicable regulations for GxP systems. Oversee documentation lifecycle including validation plans, protocols (IQ/OQ/PQ), risk assessments, and traceability matrices. Maintain validated states across system lifecyclescovering implementation, upgrades, patches, and decommissioning. Collaborate closely with Quality, Regulatory, IT Security, and Operations to meet business and compliance needs. Act as subject matter expert, advising and training internal teams on validation best practices. Lead internal/external audits and manage responses and corrective actions related to IT compliance. Supervise, mentor, and grow a team of validation engineers and specialists. Manage validation efforts for cloud-based systems and platforms (especially AWS) and ensure vendor compliance. Stay current with industry trends, regulatory changes, and drive continuous improvement across validation processes.