Senior Product QA Manager
Core
Ensures products manufactured at the Sligo site meet end-user, regulatory (FDA, HPRA), and company standards through compliance with marketing authorizations, GMP, and quality systems.
Role type
Senior Product QA Manager (Pharmaceutical Manufacturing)
Builds
Commercial and New Product Introduction (NPI) batches compliant with regulatory requirements
Domain
Pharmaceutical manufacturing / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance (FDA/EMA), GMP adherence, Change Management, Team Leadership, Batch Release, Validation, Audit Management, Complaint Investigation, Recall Management, Quality Metrics Analysis
Preferred skills
QP oversight, SAP/LIMS setup, Technical decision-making, Strategic goal setting
Technologies
SAP, LIMS
Responsibilities
Manage QP, Regulatory, Change Management, and NPI teams; Lead batch review and release; Oversee validation of manufacturing processes; Conduct internal/external audits; Manage complaint investigations and recalls; Execute regulatory submissions and engage with agencies; Chair Change Review Boards; Review and approve Product Quality Reviews (PQRs).