Director – GCP Quality Assurance Lead

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Prilenia

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11 - 50 Mitarbeiter

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

💰 €43.000.000 Series B im 2021-11

Healthcare • Biotechnology • Pharmaceuticals

Prilenia widmet sich der Entwicklung neuer Behandlungen für Patienten und Familien, die mit neurodegenerativen Erkrankungen und neurodevelopmentalen Störungen konfrontiert sind, wie zum Beispiel der Huntington-Krankheit und Amyotropher Lateralsklerose (ALS). Sie konzentrieren sich darauf, die neuroprotektiven Fähigkeiten des Gehirns zu nutzen, insbesondere durch die Aktivierung des Sigma-1-Rezeptors (S1R), um beeinträchtigte Signalwege im Gehirn wiederherzustellen. Prilenia treibt die wissenschaftliche Forschung voran und erkundet potenzielle Behandlungen, um Hoffnung zu geben und das Leben der Patienten und ihrer Familien zu verbessern.

Beschreibung

• 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.

🎯 Anforderungen

• 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)

🏖️ Vorteile

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