Sr. Manager, Quality Excellence
Core
Lead Quality Management Representative for a regulated manufacturing site, ensuring compliant execution, monitoring, and continuous improvement of the QMS in line with certification requirements and customer expectations.
Role type
Senior Manager, Quality Excellence (Regulated Manufacturing)
Builds
Quality Management Systems (QMS), compliant production processes, and high-performing quality departments for life sciences diagnostics and biotechnology.
Domain
Life Sciences, Diagnostics, Biotechnology, Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) implementation and optimization, regulatory compliance (FDA, cGMP, ISO 9001, ISO 13485), risk assessment and management, audit leadership, team development and performance management, statistical process control, Lean Manufacturing, Six Sigma, root cause analysis, budget management.
Preferred skills
Analytical chemistry, microbiology, contamination control, sterilization, SAP, Oracle, VEEVA.
Technologies
SAP, Oracle, VEEVA, Magic
Responsibilities
Serve as Quality Management Representative ensuring regulatory compliance and customer satisfaction; Implement, maintain, and optimize the Cytiva QMS; Collaborate with leadership to address process changes and drive customer-centric solutions; Build a high-performing quality department fostering safety and continuous improvement; Lead Quality Management Reviews, define KPIs, host audits, and represent the site in executive discussions.
Seniority
Senior Manager, hands-on leadership
