QA Senior Specialist, Quality System
Core
Senior-level quality and compliance expert implementing, maintaining, and improving the Quality Management System (QMS) to ensure GMP compliance and regulatory expectations across the pharmaceutical product lifecycle.
Role type
Senior IC Quality System Specialist
Builds
Quality Management System (QMS) for pharmaceutical products
Domain
Biopharmaceuticals / Quality Assurance
Required skills
GMP compliance, deviation management, CAPA, change control, document control, quality risk management, complaint management, product recall, FMEA, trend analysis, audit support, systemic issue identification, stakeholder influence, data integrity
Preferred skills
Setting up quality systems for new sites, biopharma commercial quality systems experience
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Manage and maintain assigned quality system activities ensuring GMP compliance; Lead quality system activities including deviation management, CAPA, change control, and document control; Monitor quality system performance through metrics and trend analysis; Identify systemic issues and drive sustainable improvements; Support internal, external audits and regulatory inspections; Facilitate risk assessments using FMEA; Lead complex deviation investigations and cross-functional problem solving; Promote a culture of quality ownership and continuous improvement.
Seniority
Senior, hands-on IC
