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

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.

Requirements

• 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 director-level role at a biotech company.
• Demonstrated expertise across GCP, GvP, and GLP quality frameworks; hands-on experience conducting and managing audits in all three domains.
• Deep knowledge of ICH E6(R2/R3), ICH E2 series, FDA 21 CFR Parts 11/50/54/56/312, EU Clinical Trials Regulation (No. 536/2014), EU GvP modules, and OECD Principles of GLP.
• Proven experience leading or managing regulatory authority inspections (FDA, EMA, MHRA, or equivalent) to successful outcomes.
• Experience building or significantly maturing a QMS in a small-to-mid-size pharmaceutical setting.
• Proficiency with eTMF systems (e.g., Veeva Vault, Wingspan) and electronic QMS platforms.
• Exceptional communication skills; ab le to translate complex regulatory requirements into clear guidance for diverse audiences.
• High ly autonomous, proactive, and resilient; comfortable in a fast-paced, resource-efficient environment.
• Experience in neurology, neurodegenerative disease, or rare disease clinical programs.
• Familiarity with risk-based monitoring (RBM), centralized monitoring, and ICH E6(R3) risk-proportionate approaches.
• Professional certification: RQAP-GCP (SQA), RAC (RAPS), CCRA (ACRP), or equivalent.
• Experience supporting NDA/BLA/MAA submissions and post-approval quality oversight.
• Knowledge of 21 CFR Part 11 / Annex 11 (computerized systems) and data integrity principles (ALCOA+).

Additional Information

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 https://Prilenia.com

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