Director, IT Validation - Remote

Overview

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.

In Short

• 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.

Requirements

• Proven experience in IT validation within a regulated environment.
• Strong knowledge of GxP regulations and compliance standards.
• Experience with cloud-based systems, particularly AWS.
• Excellent leadership and mentoring skills.
• Ability to manage multiple projects and priorities effectively.
• Strong communication and collaboration skills.
• Detail-oriented with a focus on quality and compliance.
• Familiarity with audit processes and corrective action management.
• Ability to stay updated on industry trends and regulatory changes.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional development and growth.
• Dynamic and collaborative work environment.
• Impactful role within a fast-growing organization.
• Access to cutting-edge technology and resources.