Quality expert-IMP

QUALITY EXPERT-IMP Location: Cork (onsite engagement required, ideally 3 days weekly) If person resides outside of Ireland, that is ok, but occasional visits to Cork a must to be okay to come and back when the company needsProject Duration: Through 2028OverviewThe company is seeking an experienced QA professional with expertise in Investigational Medicinal Products (IMPs) to lead all quality and regulatory activities associated with an immunotherapy biodegradable product currently in feasibility stage and moving toward Phase I clinical trials.This is a key subject matter expert (SME) role — the successful candidate will be the sole in-house authority on IMP compliance, guiding the organisation through regulatory, quality, and GMP-readiness activities.Scope of the RoleThis position spans the Quality and Regulatory functions, bridging two systems:Existing Medical Device Quality System, andNewly established Pharma Quality System (PQS)The QA IMP Expert will:Develop and implement quality procedures and frameworks from scratch — no procedures currently exist.Lead IMP filings, managing CDMO/CMO relationships and ensuring regulatory compliance across all activities.Oversee CMC, quality, and regulatory integration activities to ensure GMP readiness for scale-up by Q2 next year.Prepare and execute drug substance and drug product assessments ahead of manufacturing and filing milestones.Anticipate and close compliance and documentation gaps — must be proactive, not reactive.Ensure seamless collaboration between internal stakeholders (QA, CMC, Regulatory, Project Management) and external partners.Key RequirementsRecent, hands-on experience in IMP QA, with deep understanding of current regulations and guidance (EU/FDA).Proven expertise in drug substance and drug product quality — combination product experience highly advantageous.Strong background in CMC, CDMO oversight, and regulatory submission preparation.Capable of building a quality system from the ground up — writing and implementing all procedures and processes.Able to operate independently