Director / Senior Director, GCP Quality Assurance Lead
- Role
- QA
- Experience
- Senior
- Employment
- Full-time
Open to Anywhere in EU + US. Set where you work from to check your eligibility.
No BS summary
Senior clinical QA leader for a clinical-stage biotech running phase 3 trials in Huntington's and ALS. Owns GCP quality end-to-end, deep GCP/GVP/GLP expertise, and the executive presence to drive cross-functional teams. This is a hands-on and strategic role, likely based in the US, Israel, or the 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 Director/Senior Director, GCP Quality Assurance Lead, 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.
About the role 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.
What you'll do
- Serving as Prilenia's primary quality lead for clinical development, owning GCP quality end-to-end from study start-up through inspection readiness
- Serving as sponsor QA counterpart to our CRO(s) and Ferrer's QA team
- Providing proportionate QA oversight for pharmacovigilance (GVP) and pre-clinical (GLP) activities
- Acting as a strategic partner to Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics
- Combining hands-on quality practice with the executive presence to influence cross-functional teams and senior leadership
What they require
- Deep GCP/GVP/GLP expertise
- Experienced in enabling success in a hands-on quality practitioner and strategic partner role
- Executive presence to influence cross-functional teams and senior leadership
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 Director/Senior Director, GCP Quality Assurance Lead, to support programs in both Huntington’s Disease and ALS.