Associate Director, Computer System Validation & Quality Compliance

<div class="content-intro"><p>Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).</p> <p>Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.</p></div><p><strong>The Opportunity</strong></p> <p>The Associate Director, Computer System Validation (CSV) & Quality Compliance provides enterprise‑level leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxP‑relevant computerized systems, with a strong emphasis on the Veeva Quality Suite. This role ensures that digital quality solutions and supporting systems meet global regulatory requirements (FDA, EMA, ICH, GAMP 5), maintain data integrity, and enable a sustainable, inspection‑ready state across the organization.</p> <p>This person will partner closely with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, lead new system implementations and major enhancements, and drive harmonized, risk‑based validation practices. This role also oversees quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely closure, trend analysis, and effective governance through leadership of key forums including Quality Management Review and cross‑functional compliance meetings.</p> <p><strong>Responsibilities</strong></p> <p><em>Strategic Leadership & Governance</em></p> <ul> <li>Develop, evolve, and steward the corporate CSV/CSA strategy, ensuring alignment with enterprise digital strategy and Quality Management System (QMS) objectives.</li> <li>Serve as the senior Quality authority for computerized systems validation, data integrity, and electronic system compliance.</li> <li>Oversee enterprise-wide governance programs, ensuring standardized, risk‑based approaches to system implementation and maintenance.</li> <li>Provide strategic guidance to senior leadership regarding system performance, risks, and compliance maturity.</li> </ul> <p><em>Computer System Validation & Lifecycle Oversight</em></p> <ul>