Director of Quality (Europe) – Hybrid, Ireland-BasedLocation: IrelandPosition Type: Full-Time, Hybrid – 3 days/week onsiteOverviewOur client is a leading Rare Disease biopharmaceutical company committed to advancing innovative treatments to improve patient outcomes. Their mission is to transform care by delivering cutting-edge therapies while fostering strong scientific engagement with healthcare professionals and researchers.Our client is seeking a highly experienced Director of Quality (Europe) to lead regional Quality operations and support the organization's transition from clinical development to commercial readiness.This is a key strategic role responsible for building and overseeing the Quality function in Europe, ensuring ongoing compliance with GxP regulations, and serving as a regional Quality lead in collaboration with global teams.Key ResponsibilitiesEstablish, implement, and manage quality systems to ensure compliance with EU and global GxP regulations (GMP, GDP, GCP).Lead Quality strategy and execution for commercial launch preparation in the EU region.Serve as the primary European Quality lead, coordinating with cross-functional global teams including Regulatory Affairs, Manufacturing, Supply Chain, and Clinical Operations.Act as the quality representative in cross-functional launch readiness activities.Build and oversee Quality Management Systems (QMS) appropriate for commercial operations, including deviation management, CAPA, change control, and vendor oversight.Support qualification and oversight of third-party manufacturers, distributors, and service providers.Collaborate closely with global QA/QC teams to align systems, processes, and compliance expectations.Provide leadership during inspections and audits by EU regulatory authorities.Drive continuous improvement and operational excellence within the quality function.Represent the EU region in global quality discussions and contribute to global policy and SOP development.Qualifications & ExperienceMinimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry.Proven leadership experience in a GxP-regulated environment, with a strong understanding of EU regulatory requirements.Experience supporting product launches, ideally including rare or orphan drug launches within the EU.Demonstrated success operating in a dynamic, cross-functional, and international setting.In-depth understanding of GxP principles across clinical and commercial stages.Strong experience working with third-party manufacturers and logistics providers in a QA/QC capacity.Exceptional communication and collaboration skills, with the ability to operate as a strategic liaison between regional and global teams.Fluent in English; additional European language(s) a plus.Bachelor's or Master's degree in life sciences or a related field; advanced degrees or quality certifications (e.g., QP, ISO Lead Auditor, etc.) preferred.