Director​/Senior Director, GCP Quality Assurance Lead; US​/IL​/EU

About Prilenia

Prilenia Therapeutics, a clinical‑stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Medical Science Liaison (MSL) in the United States, to support programs in both Huntington’s Disease and ALS.

We are a flexible, fast‑moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD.

Prilenia is conducting global Phase 3 clinical trials in both HD and ALS.

Pridopidine has the potential to be a pivotal treatment to address HD and ALS disease progression. Prilenia believes pridopidine’s novel mechanism of action as a Sigma‑1 receptor agonist also gives it potential in numerous other neurodegenerative and neurodevelopmental conditions.

To learn more about our story and company culture, visit us at

The Director/Sr. Dir, GCP Quality Assurance is Prilenia's primary quality lead for clinical development, owning GCP quality end‑to‑end from study start‑up through inspection readiness, and serving as sponsor QA counterpart to our CRO(s) and Ferrer's QA team. The role also provides proportionate QA oversight for pharmacovigilance (GVP) and pre‑clinical (GLP) activities.

The ideal candidate is both a hands‑on quality practitioner and a strategic partner to Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics, combining deep GCP/GVP/GLP expertise with the executive presence to influence cross‑functional teams and senior leadership.

• Ensure all Prilenia‑sponsored trials are conducted, documented, and reported in compliance with applicable regulations, ICH guidelines, and Prilenia's SOPs.
• Serve as Prilenia's day‑to‑day QA lead for Phase 3 clinical operations, embedded in the program team from protocol review through clinical study report sign‑off.
• Act as sponsor QA counterpart to CRO QA teams and to Ferrer's QA function, maintaining quality oversight of outsourced trial execution, aligning on standards, and managing issue escalation.
• Oversee eTMF quality, manage protocol deviations and GxP non‑conformances, drive CAPA resolution with CROs and sites, and maintain continuous inspection readiness.
• Lead inspection readiness and management for regulatory authority inspections (FDA, EMA, MHRA, PMDA); serve as primary QA contact, coordinate responses to observations, and oversee regulatory commitment closure.
• Author and maintain GCP and related SOPs; define and track quality metrics and KPIs for senior leadership.
• Oversee clinical site, CRO, and vendor audits; review reports, manage CAPA resolution; review and approve Quality Agreements.

• Serve as GVP QA partner and SME to Drug Safety: oversee PV systems, vendor quality performance, and vendor audits; support CAPA resolution for safety findings; ensure compliance with EU GvP modules, FDA 21 CFR Part 312, and ICH E2 series.
• Serve as GLP QA partner and SME for externally conducted pre‑clinical studies; ensure compliance with OECD Principles of GLP and applicable national regulations.

• Contribute to Prilenia's fit‑for‑purpose QMS, SOP lifecycle, quality event tracking, training, and regulatory intelligence.
• Represent QA on clinical program teams and relevant governance forums.
• Champion a proactive quality and compliance culture, making quality an enabler of clinical program success rather than a compliance exercise.
• Mentor junior QA staff and foster professional development within the quality function.

• Bachelor’s degree or higher in life sciences, pharmacy, or a related discipline; advanced degree (MSc, PharmD) preferred.
• Minimum 10 years of GCP QA experience within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership or…