Senior Manager, Quality
Core
Site Quality leader for a regulated chemical manufacturing facility, overseeing Quality Assurance, Quality Control, and the Quality Management System to ensure cGMP compliance and drive continuous improvement.
Role type
Senior Manager, Quality
Builds
Production of regulated chemical products for life sciences and pharmaceutical customers
Domain
Chemical manufacturing / cGMP / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems, CAPA, Risk Management, Supplier Quality, Audits and Inspections, Validation and Qualification, Quality Control Operations, Lean, Six Sigma, PFMEA, SPC, Change Management, Labor Relations, Collective Bargaining Agreements
Preferred skills
Unionized manufacturing operations, Large-scale quality transformation, Professional quality organization membership
Technologies
Lean, Six Sigma, PFMEA, SPC, CAPA
Responsibilities
Champion site-wide quality culture and compliance with cGMP/FDA requirements, Lead quality transformation and continuous improvement initiatives, Develop and mentor Quality leaders and supervisors, Foster productive labor-management relationships and interpret collective bargaining agreements, Oversee QA/QC operations including batch disposition and supplier quality, Ensure readiness for regulatory and customer audits
Seniority
Senior, hands-on IC with leadership mandate
