Director of Quality (Europe) – Hybrid, Ireland-Based
Location
: Ireland
Position Type
: Full-Time, Hybrid – 3 days/week onsite
Overview
Our 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 Responsibilities
* Establish, 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 & Experience
* Minimum 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.