Head of Quality Assurance — Pharma, Digital QMS Leader
HERO Recruitment Ltd.
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Descripción de la vacante
HERO Recruitment Ltd. is supporting a Galway-based pharmaceutical manufacturer in appointing a Head of Quality Assurance. This senior role leads QA operations across aseptic manufacturing, ensures EU GMP compliance and oversees the new ERP/QMS digital journey.
You will own quality strategy, batch release, QP activities and regulatory inspections, with clear progression to Group Head level. Ideal candidates have 10–15 years in pharmaceutical quality, active EU/EEA QP certification, and proven
Formación
- QP certification active in EU/EEA
- Hands-on aseptic manufacturing experience
- 10–15 years in pharmaceutical quality within GMP environment
- Experience leading multidisciplinary quality teams
- Experience managing quality across multiple jurisdictions incl. remote/offshore CMOs
- Front-line regulatory inspection experience, ideally FDA
Responsabilidades
- Lead QA Operations across an aseptic site and CMOs
- Own batch review, disposition, certification and release
- Set KPIs and quality metrics and drive performance
- Coach and develop leaders and teams
- Drive digital journey including eQMS, LIMS and ERP integration
- Engage with regulators, customers and suppliers on quality
- Build and execute a Quality Strategy aligned with growth
Conocimientos
Educación
Herramientas
Descripción del empleo
HERO Recruitment Ltd. is supporting a Galway-based pharmaceutical manufacturer in appointing a Head of Quality Assurance. This senior role leads QA operations across aseptic manufacturing, ensures EU GMP compliance and oversees the new ERP/QMS digital journey.
You will own quality strategy, batch release, QP activities and regulatory inspections, with clear progression to Group Head level. Ideal candidates have 10–15 years in pharmaceutical quality, active EU/EEA QP certification, and proven
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