Site Self Inspection Lead, Quality Assurance - 1st Shift
Core
Lead site self-inspections and quality assurance processes to ensure compliance with pharmaceutical cGMP and global regulations.
Role type
Senior Quality Assurance Lead (Site Self-Inspection)
Builds
Site self-inspection plans, CAPA tracking, audit readiness, and trend reports for global quality initiatives.
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Required skills
Pharmaceutical cGMP knowledge, Global GMP application, CAPA management, Audit planning and execution, Trend analysis, Training and coaching, Supplier audit coordination, Regulatory compliance (FDA, WHO, EMA, ICH, ISO 9001)
Preferred skills
Experience with Site Audit Module, Board of Health inspections, Global Operations Audits
Technologies
GXP systems, Audit management tools
Responsibilities
Create and track site self-inspection plans and agendas; Lead and participate in site self-inspections and facility walkthroughs; Evaluate and track CAPA items and verify effectiveness; Prepare annual trend reports and facilitate bi-monthly reviews; Support site Inspection Readiness Plan and Board of Health inspections; Perform external audits of third-party suppliers; Provide training and coaching to site teams.
Seniority
Senior, hands-on IC