Quality Manager
Core
Oversee quality assurance and control activities to ensure compliance with cGMP and regulatory standards in pharmaceutical manufacturing.
Role type
Quality Manager (GMP-regulated manufacturing)
Builds
Quality Management System (QMS) and compliant manufacturing operations
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
cGMP compliance, QMS management, deviation management, CAPA, change control, risk assessment, audit support, regulatory inspection readiness, cross-functional collaboration, quality documentation review, performance monitoring, team leadership
Preferred skills
Team development, stakeholder management
Technologies
GMP, QMS, CAPA, Change Control, Risk Management
Responsibilities
Oversee QA/QC activities for regulatory compliance; Maintain and improve the QMS; Lead investigations into deviations and implement CAPA; Manage change controls and risk assessments; Support internal/external audits and regulatory inspections; Collaborate with cross-functional teams to resolve quality issues; Review and approve quality documentation; Monitor quality performance indicators; Provide leadership and training to quality personnel; Escalate and resolve critical quality issues impacting patient safety or compliance
