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 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

• 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.

Benefits

• Competitive salary package with performance-based incentives.
• Full medical, dental, and vision insurance.
• 401(k) with company match.
• Generous PTO and holiday schedule.
• Onsite role in a collaborative, innovation-driven biotech environment.
• Professional development support and career growth opportunities.
• Inclusive, mission-oriented company culture with meaningful impact in rare disease research.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

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