QC Lead - Bioassay

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 & Analytical Method Development
• Cell Culture & Potency Assays
• GMP Compliance & Quality Systems
• Deviations, Investigations & CAPAs
• Laboratory & People Management
• Vaccine Manufacturing & Virology

What's on Offer

• Opportunity to lead a critical function within a growing, high tech facility
• Work on impactful vaccine products with global reach
• Collaborative and innovation driven environment
• Strong opportunities for career development and progression