# Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)

[Prilenia](https://gurify.com/jobs?q=Prilenia) · Boston, MA · Posted 2 months ago

Director

[QA](https://gurify.com/jobs/qa)

[Cloud](https://gurify.com/jobs/cloud)

[Apply on the original posting → (opens in a new tab)](https://jobs.lever.co/prilenia/1db7c4c4-9b84-4c07-b9ed-85f7aca5bbe5/apply)

## Job description

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.
To learn more about our story and company culture, visit us at https://Prilenia.com

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.

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.
To learn more about our story and company culture, visit us at https://Prilenia.com

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.

**Live in Prilenia’s hiring system.** Read from the company's own applicant tracking system, not reposted from a job board — so it's a real, open requisition rather than an ad that outlived the role.

We remove it as soon as it disappears at source.

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