Sr. Specialist, QA Systems
Core
Execute and enhance quality systems and compliance activities within a GxP-regulated biopharmaceutical environment.
Role type
Senior Specialist, Quality Assurance Systems
Builds
Quality Management System (QMS) processes and data integrity
Domain
Biopharmaceuticals / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
GxP compliance, document control, deviation management, CAPA, change control, vendor management, audit support, data integrity, electronic quality systems, root cause analysis, process improvement
Preferred skills
Mentorship, cross-functional collaboration, stakeholder influence
Technologies
LMS, QMS, standard computer applications
Responsibilities
Coordinate complex QA activities including document control, vendor management, audits, investigations, and product complaints; ensure accuracy and traceability of QA records; review and process controlled documents and SOPs; generate and analyze reports, metrics, and dashboards for QA performance monitoring; support inspection and audit readiness; identify and escalate quality issues; lead process improvement efforts; provide guidance to less experienced team members.
Seniority
Senior, hands-on IC with mentorship responsibilities