Company Overview:

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary:

The Director of IT validation leads the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders—especially within GXP environments. This role focuses on the development, execution, and management of IT validation strategies and initiatives for systems across the organization. The Associate Director, IT Validation works cross functionally with IT Security, Quality, Regulatory, and Operations teams to ensure the implementation and ongoing compliance of IT systems with FDA, EMA, SOX, and other global regulations.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary Responsibilities Include:

Lead the development, planning, and execution of IT validation strategies for GxP systems, ensuring compliance with industry standards such as 21 CFR Part 11, GAMP 5, and other relevant regulations
Oversee the creation and review of validation documentation, including validation plans, protocols (IQ, OQ, PQ) risk assessments, and traceability matrices
Ensure IT systems are maintained in a validated state throughout their life cycle, including upgrades, patches and decommissioning activities. Collaborate with cross functional teams such (e.g., Quality, Regulatory, IT and Operations) to ensure systems meet business needs and regulatory requirements
Serve as the subject matter expert on IT Validation—providing guidance and training to protect teams and stakeholders
Manage and mentor a team of validation engineers and specialists, ensuring best practices are followed
Lead internal and external audits related to IT validation and compliance, preparing responses and driving corrective actions
Maintain up-to-date knowledge of global regulatory requirements, validation methodologies, and industry trends, and implement continuous improvement initiatives.
Partner with vendors and consultants to ensure external systems and applications are validated in accordance with company policies. Provide oversight of validation efforts for cloud-based systems and applications, ensuring compliance with GXP requirements

Education and Skills Requirements:

A bachelor's degree in computer science, Information Technology, engineering or related field. Advanced degree preferred
Minimum of 10 years of experience in IT validation, including three years in a leadership role with GXP regulated environments
In-depth knowledge of FDA regulations. Including 21 CFR Part 11, GAMP 5 and other relevant global regulatory requirements
Experience with validation of cloud-based systems and platforms in AWS
Proven ability to manage multiple validation projects in a fast-paced environment
Strong leadership skills with experience in mentoring and developing high performing teams
Excellent verbal and written communication skills with the ability to effectively communicate with stakeholders at all levels of the organization
Experience in managing validation activities during internal and external audits
Experience managing evidence Collection and dissemination for assessments and audits
Excellent analytical and problem-solving skills
Ability to thrive in a fast-paced and dynamic environment
Outstanding vendor management skills
Certification in quality or validation (e.g., ASQ, ISPE) a plus.

#LI-Onsite