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.
Key responsibilities include:
- 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
This is a foundational role, offering significant autonomy and the opportunity to build systems and processes from the ground up within a scaling organisation
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
The Next Step for you:
Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1 6498546
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
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