GCP质量保证负责人（美国/伊利诺伊州/欧洲）

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.

Roles and Responsibilities:

GCP Quality - Core Focus

• 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, maintain quality oversight of outsourced trial execution, align on standards, and manage 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.

QA Partnership & SME for GLP and GVP

• 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.

QMS & Cross-Functional Leadership

• 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.

Qualifications:

Required

• 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; able to translate complex regulatory requirements into clear guidance for diverse audiences.

• Highly autonomous, proactive, and resilient; comfortable in a fast-paced, resource-efficient environment.

Desirable

• 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+).

Location/Time Zones:

• This is a full-time remote position in the East Coast US, Israel or Europe.

• Flexible schedule with frequent calls across Israel, North America and Europe time zones.

• Occasional travel including internationally within US and Europe required.