Dearbhla Byrne

Senior Consultant, GxPAssure

A highly accomplished Pharma, Biopharma, and ATMP consultant with over 20 years of experience delivering strategic and operational excellence across the pharmaceutical and biopharmaceutical sectors. Demonstrated expertise in regulatory compliance, quality assurance, and advanced therapy medicinal products, with a proven ability to lead complex projects and drive continuous improvement in quality systems.

Dearbhla has held key leadership and regulatory roles thoughout her career, including GMP Inspector at the Health Products Regulatory Authority (HPRA). These positions have equipped Dearbhla with a deep understanding of global regulatory frameworks, inspection protocols, and best practices for maintaining compliance in highly regulated environments.

Core competencies include:

• Regulatory Compliance & Inspection Readiness: Conducting mock inspections, preparing facilities and personnel for regulatory audits, and providing inspection support and remediation strategies.
• Quality Systems Development: Designing, implementing, and enhancing robust quality management systems to meet GMP/GxP standards and reduce compliance risks.
• Risk Management & Contamination Control: Developing contamination control strategies and implementing quality risk management processes to safeguard product integrity.
• QP Responsibilities & Licence Applications: Managing QP batch disposition, overseeing manufacturing licence applications and variations, and ensuring adherence to regulatory requirements.
• Validation & QC Expertise: Leading validation of processes, equipment, and facilities, and managing comprehensive QC activities to maintain product quality and safety.
• Auditing & Training: Conducting internal and external audits, and delivering GMP training on critical topics such as data integrity, quality systems, and risk management.

Recognized for a collaborative approach, strong leadership skills, and the ability to translate complex regulatory requirements into practical, business-focused solutions. Passionate about supporting organizations in achieving compliance excellence and operational efficiency within the evolving landscape of pharmaceutical and biopharmaceutical manufacturing.