Director – GCP Quality Assurance Lead

🕒 Junho 8

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Prilenia

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

💰 $43.000.000 Series B em 2021-11

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Prilenia é dedicada ao desenvolvimento de novos tratamentos para pacientes e famílias que enfrentam doenças neurodegenerativas e distúrbios do neurodesenvolvimento, como a doença de Huntington e esclerose lateral amiotrófica (ELA). Eles se concentram em aproveitar as capacidades neuroprotetoras do cérebro, particularmente através da ativação do receptor sigma-1 (S1R), para restaurar vias prejudicadas no cérebro. A Prilenia está avançando na pesquisa científica e explorando potenciais tratamentos para proporcionar esperança e melhorar a vida dos pacientes e suas famílias.

Descrição

• Serve as 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. • 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. • 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.

🎯 Requisitos

• 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. • Experience in neurology, neurodegenerative disease, or rare disease clinical programs (Desirable) • Familiarity with risk-based monitoring (RBM), centralized monitoring, and ICH E6(R3) risk-proportionate approaches (Desirable)

🏖️ Benefícios

• Flexible schedule • Frequent calls across Israel, North America and Europe time zones • Occasional travel including internationally within US and Europe required