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.
Responsibilities
Strategic Leadership & Governance
Computer System Validation & Lifecycle Oversight
Veeva Systems Expertise & Optimization
Quality & Regulatory Compliance
Required Qualifications
Preferred Qualifications
Work Location and Conditions
Compensation
The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.
To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
To return to our website please click here.
Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.