Senior Quality Partner
Core
Supporting quality assurance activities on the shop floor to ensure compliance with GMP, regulatory requirements, and internal standards.
Role type
Senior Quality Partner (Manufacturing/Operations)
Builds
Manufacturing and Operations processes
Domain
Pharmaceutical/Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP standards knowledge, CAPA system expertise, root cause analysis, audit participation, SOP/NCR/CAPA review, risk identification, cross-functional collaboration, data collection and analysis
Preferred skills
Experience in multinational matrixed environments, database management, project management
Technologies
database management, spreadsheets, project management software, flowcharting tools
Responsibilities
Review and approve impact assessments for nonconformances; Act as QA reviewer and approver for SOPs, NCRs, and CAPA plans; Collaborate with Production, Supply Chain, and Engineering to identify risks and implement corrective actions; Oversee timeliness of record completion; Initiate and drive corrective and preventive actions; Support investigations into quality incidents; Participate in internal and external audits
Seniority
Senior, hands-on IC
