Social network you want to login/join with:Head of Quality - Qualified Person (IMP) | Remote, IrelandLife Science Consultancy | Broad Client Portfolio | IMP & Commercial ProductsMy client is an established and growing life science consultancy, rapidly expanding its footprint in Ireland. As part of this growth, they are seeking an experienced Qualified Person (QP) with extensive Investigational Medicinal Product (IMP) expertise to lead their quality function.This is a senior leadership role offering the opportunity to work with a diverse range of life science companies - from start-ups to established global players - across a broad mix of pharmaceutical and biopharmaceutical products, including rare disease and gene therapies.The role can be performed remotely from anywhere in Ireland and is focused on guiding clients' development products through to both European and global launches.Key Responsibilities:Provide expert guidance on EU Good Manufacturing and Distribution Practice (GMDP) both internally and to clientsLead and develop the internal GMP and GDP Quality TeamsAct as a primary contact for current and prospective clientsPerform QP duties on the organisation's IE MIA / MIA-IMP licences and client MIAs as requiredExperience & Qualifications:Minimum 10 years' pharmaceutical industry experience with in-depth knowledge of quality systems in a GMP environmentAt least 7 years of experience as a Qualified Person, eligible to be named on MIA/MIA-IMP licencesDemonstrable experience hosting GMDP regulatory inspectionsEligibility to act as a Responsible Person (RP) on a WDA(H) is desirableBroad knowledge of GMDP requirements and IMP lifecycle from development to commercialisationThis is an excellent opportunity for an experienced QP to take a senior, strategic role within a highly regarded and expanding consultancy, with exposure to a wide range of products and clients.
#J-18808-Ljbffr