Associate Director, Quality Assurance – Biopharma Manufacturing
Location: Dundalk
Lead QA Excellence in Drug Product & Drug Substance GMP Operations
Are you ready to shape the future of Quality Assurance in biopharmaceutical manufacturing? As
Associate Director, QA
, you'll provide strategic oversight for Drug Product (DP) and Drug Substance (DS) GMP operations, ensuring compliance, driving continuous improvement, and leading a high-performing QA team.
In this role, you will:
* Oversee GMP manufacturing and ensure compliance with regulatory standards.
* Lead QA support for tech transfers, PPQ, and inspection readiness.
* Build, mentor, and develop QA operations teams.
* Review and approve GMP documentation with a focus on data integrity.
* Champion continuous improvement initiatives to raise quality standards.
What you bring:
* Degree in Biopharma or related scientific field.
* 8+ years' experience in vaccine/biopharma DP/DS manufacturing (sterile filling a plus).
* Strong leadership, communication, and people management skills.
* A proven ability to collaborate across functions and solve complex challenges.
Join us and make an impact by ensuring the highest standards of quality in delivering breakthrough therapies