Eblex Group a supporting a Biotechnology business in Dublin looking for a
GMP Quality Consultant
to 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 Consultant
* Provide 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 Consultant
* Bachelor'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 Skills
* Prior 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.
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