Senior Quality Project Lead – Customer Quality
Core
Primary Quality partner supporting customer manufacturing programs within a sterile manufacturing environment, ensuring compliance with cGMP and customer requirements.
Role type
Senior Quality Project Lead (Pharmaceutical Manufacturing)
Builds
Sterile injectable, oral solid dose, softgel, and combination products for pharmaceutical and biotechnology customers
Domain
Pharmaceutical manufacturing / Sterile manufacturing / Contract Manufacturing Organization (CMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations, pharmaceutical Quality Systems, sterile manufacturing operations, deviation management, change controls, batch disposition, project leadership, risk assessment, technical writing
Preferred skills
ISO 13485 quality systems, medical device quality requirements, CMO environment experience, new product introductions, Six Sigma
Technologies
cGMP, ISO 13485
Responsibilities
Serve as Quality Project Lead for assigned customer manufacturing programs; Provide Quality oversight for manufacturing, packaging, investigations, and batch record review; Review and approve deviations, change controls, procedures, and quality records; Perform Quality batch disposition and make release decisions; Partner with cross-functional teams to support new product introductions; Interpret and apply pharmaceutical regulations; Lead compliance assessments and continuous improvement initiatives; Evaluate product and business risks; Act as technical Quality resource during investigations; Support implementation of Quality Systems.
Seniority
Senior, hands-on IC
