Head of Quality for a Global Biopharmaceutical company based in Ireland. The role will head up Quality for the manufacturing site in Ireland, overseeing all aspects of product quality. The ideal person would be a certified Qualified Person with proven line management experience and will oversee the senior leadership team. This role will be responsible for leading and directing all of the site quality organisation and functions and will report into the Global VP of QA.
Acts as primary QP for the site: Primary interface with global regulatory authority as it relates to site inspections, management of product issues/market action, product registration response to questions.
Position holder reports directly to global QA for the Pharma and Biologics division of the business and acts as primary interface on all quality compliance related activities and initiatives with the global QA team.
A BSc or MSc in Life Sciences or Ph.D.
Certified Qualified Person as per Directive 2001/83/EC for Medicinal products for human use.
Experience heading up Quality Assurance within a pharmaceutical manufacturing setting.
Extensive Quality Operations experience within a QA GMP setting within pharmaceuticals or biopharmaceuticals.
Experience hosting and overseeing Regulatory Inspections.