Assistant Manager, QA Validation
Core
Define and specify quality activities, processes, and standards for validation programs in compliance with regulatory requirements to ensure timely delivery of validated and compliant pharmaceutical products.
Role type
Assistant Manager, QA Validation
Builds
Quality infrastructure and systems for manufacturing operations
Domain
Pharmaceutical manufacturing
Required skills
Regulatory compliance (21 CFR Part 210 & 211, GMP), validation program management, team leadership, audit and monitoring, process improvement, vendor and contract manufacturer coordination, deviation and defect troubleshooting
Preferred skills
Master's degree (MS/MA)
Technologies
None stated
Responsibilities
Define and specify quality activities, processes, and standards for validation programs; Build and maintain quality infrastructure and systems; Lead and manage a team of quality professionals; Conduct audits and monitoring of validation activities and manufacturing processes; Ensure efficient workflow, procedures, policies, and validation inspection programs; Manage in-process product quality and validation outcomes; Communicate with customers and vendors to resolve quality issues; Report and troubleshoot manufacturing process deviations and defects; Identify and implement process improvements
Seniority
Manager, hands-on leadership
