Quality Manager, NPI
Core
Lead a team of Quality Professionals to manage Design Control activities and ensure on-time quality deliverables for New Product Introduction (NPI) projects of combination products and advanced drug delivery systems.
Role type
Senior Quality Manager, NPI
Builds
New product introductions (combination products, advanced drug delivery)
Domain
Biopharma / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control, GAMP 5, 21 CFR Parts 820/210/211/11, Data Integrity, Product Life Cycle Management, Design Assurance, Project Management, Risk Management, Change Control, CAPA, Cross-functional team leadership
Preferred skills
Advanced Drug Delivery Product Quality Assurance strategies, Regulatory conformance expertise, KPI definition and reporting
Technologies
GAMP 5, 21 CFR Parts 820, 210, 211, 11
Responsibilities
Lead cross-functional teams to achieve on-time quality deliverables; Develop and implement quality assurance strategies for NPI projects; Make key decisions on product quality and regulatory conformance; Manage project timelines and critical paths; Identify, evaluate, and control program risks; Ensure compliant NPI Change Requests and design reviews; Serve as NPI risk management representative; Participate in audits and regulatory inspections.
Seniority
Senior, hands-on IC
