Quality Project Manager
Core
Assure high quality products and services for drug delivery devices, ensuring compliance with regulatory requirements and customer expectations.
Role type
Senior Quality Project Manager (Manufacturing)
Builds
Drug delivery devices (inhalation, injection, nasal, dermal pumps, ophthalmic)
Domain
Pharmaceutical manufacturing / Medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Corrective and Preventive Actions (CAPA), Process validation, Equipment validation, Change control management, Risk assessment (FMEA), Statistical Process Control (SPC), Team supervision, Regulatory compliance (ISO, cGMP, FDA)
Preferred skills
Six Sigma certification, Medical device or Pharmaceutical industry experience, Strategic planning, Resource allocation
Technologies
SAP, Microsoft Excel, Microsoft Word
Responsibilities
Coordinate and execute quality goals to improve product quality and operating efficiency; Direct and coordinate activities of Quality Department employees; Establish relationships with production, technology, and supply chain teams to identify compliance gaps; Manage claims, non-conformities, and investigations; Lead CAPA activities; Manage process and equipment validations; Define and implement quality initiatives to meet KPIs; Represent the Quality Department in customer, ISO, and third-party audits; Supervise staff including hiring, training, and performance evaluation.
Seniority
Senior, hands-on IC with supervisory responsibilities
