European Associate Director, Quality Assurance
Location: Cork (Hybrid)
An exceptional opportunity for a senior Quality professional to take on a pivotal leadership role within a rapidly expanding biopharma start‑up. This position offers the chance to design and establish a robust Quality Management System (QMS) within a lean, virtual European operation, supporting ambitious commercial and pipeline growth plans.
This organisation is entering an exciting phase, with plans to launch US commercial products across multiple European markets alongside a strong development pipeline that will underpin further global expansion. You will play a central role in enabling this growth by ensuring quality systems, compliance, and governance are built to scale.
The Role
As European Associate Director, Quality Assurance, you will lead the design, implementation, and ongoing development of a compliant and inspection‑ready Pharmaceutical Quality System aligned with MAH and GDP requirements. Working within a highly collaborative and entrepreneurial environment, you will operate at both strategic and operational levels.
Designing and implementing a fit‑for‑purpose QMS to support MAH licence activities
Establishing quality governance across a virtual supply chain model
Leading oversight of contract manufacturers, testing laboratories, and distribution partners
Driving supplier qualification, audit programmes, and quality agreements
Supporting regulatory inspections and interactions with European authorities
Embedding a strong quality culture across a growing cross‑functional organisation
Contributing to long‑term quality strategy aligned with European and global expansion
Candidate Profile
Extensive experience in pharmaceutical or biopharmaceutical Quality Assurance
Proven track record in establishing or enhancing QMS/PQS frameworks
Experience operating within a virtual or outsourced supply chain model
Strong background working with CMOs, third‑party manufacturers, and distributors
Demonstrated involvement in regulatory inspections and compliance activities
Prior experience in a start‑up or high‑growth environment highly desirable
QP and/or RP certification would be a distinct advantage
Why Apply
Opportunity to shape Quality strategy within a high‑growth European platform
Visible leadership role with direct impact on product launches and market expansion
Collaborative, ambitious culture with strong international integration
Hybrid working model based in Cork
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