Eblex Group a supporting a Biotechnology business in Dublin looking for aGMP Quality Consultantto provide expert guidance and hands-on support in ensuring compliance with Good Manufacturing Practice (GMP) standards across their operations.The consultant will play a key role in maintaining regulatory compliance, supporting inspection readiness, and driving quality improvements in manufacturing, laboratory, and supply chain processes.Key Responsibilities of the GMP Quality ConsultantProvide subject matter expertise in GMP requirements (FDA, EMA, ICH, and other relevant regulatory bodies).Review and advise on quality systems, policies, and procedures to ensure compliance and best practices.Support audit preparation, host/participate in regulatory inspections, and manage responses to findings.Conduct internal audits and gap assessments of GMP facilities, equipment, and documentation.Develop and deliver training on GMP principles, quality systems, and compliance topics.Review and approve quality documentation, including SOPs, batch records, deviations, CAPAs, and change controls.Provide guidance on validation and qualification activities (equipment, facilities, utilities, processes).Support quality oversight of external partners (CMOs, CROs, and suppliers).Advise cross-functional teams on GMP implications of product development, scale-up, and commercialization.Identify and implement process improvements to strengthen quality culture and reduce compliance risks.Qualifications of the GMP Quality ConsultantBachelor's degree in Life Sciences, Biotechnology, Pharmacy, or related field; advanced degree preferred.7+ years of experience in Quality Assurance/Compliance within the biotech or pharmaceutical industry.Strong knowledge of global GMP regulations (FDA, EMA, ICH, PIC/S).Proven track record of supporting regulatory inspections and audits.Experience with quality systems (deviations, CAPA, change control, training, document management).Familiarity with validation principles (CSV, process, equipment, and cleaning validation).Preferred SkillsPrior consulting experience in biotech or pharmaceutical companies.Experience with advanced therapies (cell and gene therapy, biologics, ATMPs).Knowledge of GxP areas beyond GMP (GLP, GCP) is an advantage.Lean/Six Sigma or continuous improvement background.GMP Quality Consultant | GMP | Pharma | Biotech | QA | Quality | GMP | Validation | Cell and gene | CAPA | CC | Change Control | Life Science | QMS | Quality Systems