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Director, IT Validation at Jobgether. 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 lifecycles—covering 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.. . . Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field (Master’s preferred).. . Minimum 10 years of experience in IT validation, with at least 3 years in a leadership role within GxP-regulated environments.. . Strong expertise in regulatory frameworks including FDA 21 CFR Part 11, GAMP 5, and other international compliance standards.. . Demonstrated success validating cloud-based platforms (e.g., AWS) and managing multi-system validation projects.. . Proven track record of managing audits, corrective actions, and compliance documentation.. . Strong communication skills and the ability to collaborate with stakeholders at all organizational levels.. . Leadership and team development experience with a focus on quality and performance.. . Experience collecting and managing evidence for audits and assessments.. . Analytical and problem-solving mindset with the ability to prioritize in a fast-paced setting.. . Industry certifications (ASQ, ISPE, etc.) are a plus.. . Company Location: United States.