Associate Director, Computer System Validation & Quality Compliance
About The Position
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). 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. The Opportunity 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. 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.
Requirements
- Bachelor’s degree in a relevant scientific or technical discipline.
- 8+ years of experience in the life sciences industry with strong GxP system experience.
- Extensive leadership experience in cross functional implementation and validation of GxP computerized systems.
- Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training, etc.).
- Strong knowledge of global regulatory expectations and data integrity frameworks.
- Demonstrated ability to lead enterprise programs, influence stakeholders, and drive compliant decision making.
Nice To Haves
- Expertise with SaaS/cloud architectures and database compliance expectations.
- Understanding of clinical data collection technologies and supporting data processes.
- Familiarity with SDLC, Agile methodologies, CSV vs. CSA principles and automated testing platforms.
- Experience developing and interpreting Quality metrics such as KPIs and KQIs.
- Excellent communication skills with the ability to collaborate, negotiate, and influence at all organizational levels.
Responsibilities
- Strategic Leadership & Governance
- Develop, evolve, and steward the corporate CSV/CSA strategy, ensuring alignment with enterprise digital strategy and Quality Management System (QMS) objectives.
- Serve as the senior Quality authority for computerized systems validation, data integrity, and electronic system compliance.
- Oversee enterprise-wide governance programs, ensuring standardized, risk‑based approaches to system implementation and maintenance.
- Provide strategic guidance to senior leadership regarding system performance, risks, and compliance maturity.
- Computer System Validation & Lifecycle Oversight
- Lead planning, execution, review, and approval of validation deliverables across GxP systems.
- Oversee system lifecycle activities including impact assessments, change management, periodic reviews, audit trails, user access reviews, and system retirement.
- Promote and reinforce CSA‑aligned, risk‑based validation practices to streamline compliance and maximize efficiency.
- Ensure documentation quality and consistent application of SDLC principles across projects.
- Veeva Systems Expertise & Optimization
- Serve as the Quality SME for the Veeva Quality Suite, providing expert guidance on configuration, workflow optimization, and release readiness.
- Lead implementation, enhancement, and optimization of Veeva Vault modules and cross‑functional integrations.
- Drive automation and digitization initiatives that improve usability, compliance, and system performance.
- Partner with IT and Veeva administrators to maintain robust, compliant change control processes.
- Quality & Regulatory Compliance
- Ensure all computerized systems maintain compliance with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations.
- Author, revise, and own Quality System policies and procedures related to electronic systems and validation.
- Represent Quality during internal audits, external regulatory inspections, and vendor assessments.
- Lead timely remediation, effectiveness checks, and continuous improvement initiatives.
- Provide oversight and trending for Quality Events related to system performance or compliance.
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What This Job Offers
Job Type
Full-time
Career Level
Director
