Prilenia

QA Engineer

• 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.

Director – GCP Quality Assurance Lead