Job Description
Job Description
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.
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