QC Lead – Bioassay (Vaccines) Dundalk, Ireland An exciting opportunity has arisen for an experienced QC Lead – Bioassay to join a state-of-the-art vaccine manufacturing facility in Dundalk.
This role offers the chance to lead a high-performing team and play a critical part in delivering high-quality vaccine products that have a global impact.
The Role As QC Lead, you will be responsible for leading the Bioassay team and ensuring the highest standards in quality control, compliance, and scientific excellence within a GMP environment.
Key Responsibilities Lead, develop, and grow a high-performing QC Bioassay team, including recruitment, coaching, and training Act as a technical expert for the development, qualification, and validation of bioassay and cell-based potency methods Review and approve technical documentation including protocols and validation reports Provide technical leadership and evaluate new analytical technologies Oversee quality systems including deviations, investigations, change controls, and CAPAs Manage laboratory scheduling and planning to ensure efficient operations Collaborate with cross-functional teams including Quality Assurance and Regulatory Affairs Support regulatory inspections and GMP audits, driving continuous improvement initiatives About You Essential Degree (BSc or MSc) in Biology, Biochemistry, Immunology, Virology, or a related discipline Strong experience in QC and analytical operations within biopharmaceutical or vaccine environments In-depth knowledge of GMP and regulatory requirements (cGMP, ICH, EMA, FDA) Proven leadership and people management experience Strong problem-solving and communication skills Experience working collaboratively across multiple functions Desirable PhD in a relevant scientific field Significant industry experience (8+ years in vaccines or 10+ years in biopharma) Experience in viral testing and biosafety environments (e.g., BSL-3) Background in CMC development or GMP manufacturing Demonstrated experience driving continuous improvement initiatives Key Skills Bioassay