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Associate Director of Computer System Validation & Quality Compliance

On-site Full-time $170K/yr - $191K/yr

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Experience Level

Senior Level Manager

Qualifications

Responsibilities:Strategic Leadership & GovernanceDevelop, evolve, and steward the corporate CSV/CSA strategy to align with enterprise digital strategy and Quality Management System (QMS) objectives. Act as the senior Quality authority for computerized systems validation, data integrity, and electronic system compliance. Oversee enterprise-wide governance programs to implement standardized, risk-based approaches for system implementation and maintenance. Provide strategic advice to senior leadership on system performance, risks, and compliance maturity. Computer System Validation & Lifecycle OversightLead the validation of computerized systems throughout their lifecycle, ensuring compliance with regulatory standards. Implement and maintain a robust validation framework that supports operational excellence.

About the job

Amylyx Pharmaceuticals is dedicated to revolutionizing the treatment of diseases with significant unmet needs. We embrace challenges as opportunities, driven by a sense of urgency, rigorous scientific methodology, and a steadfast commitment to the communities we serve. Our focus is on clinical-stage development for conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission thrives on our talented team, which embodies core values of audacity, curiosity, authenticity, engagement, and accountability — all of which foster a culture of care. Amylyx has curated a skilled workforce ready to act swiftly because the communities we support cannot afford to wait. If you are passionate about addressing some of the most challenging issues in medicine, we invite you to explore the opportunity below and apply.

The Opportunity

The Associate Director of Computer System Validation (CSV) & Quality Compliance will provide enterprise-level leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxP-relevant computerized systems, particularly focusing on the Veeva Quality Suite. This position is pivotal in ensuring that our digital quality solutions and supporting systems comply with global regulatory standards (FDA, EMA, ICH, GAMP 5), safeguard data integrity, and maintain a sustainable, inspection-ready status across the organization.

This role entails close collaboration with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, oversee new system implementations and significant enhancements, and promote harmonized, risk-based validation practices. Additionally, this position supervises quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely resolutions, trend analysis, and effective governance through leadership of key forums, including Quality Management Review and cross-functional compliance meetings.

About Amylyx Pharmaceuticals, Inc.

Amylyx Pharmaceuticals is a pioneering clinical-stage company committed to transforming treatment paradigms for diseases with high unmet medical needs. Our innovative approach is fueled by a dedicated team that prioritizes rigorous scientific inquiry and a profound commitment to those we serve.

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