Sr. Specialist, QA Systems
Core
Execute and enhance quality systems and compliance activities within a GxP-regulated biopharmaceutical environment, ensuring adherence to regulatory requirements and internal procedures.
Role type
Senior Specialist, Quality Assurance Systems
Builds
Quality Management System (QMS) processes, electronic quality systems, and audit readiness
Domain
Biopharmaceuticals / GxP Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
GxP knowledge, document control, change control, CAPA, deviation management, vendor management, audit coordination, data integrity, root cause analysis, electronic quality systems administration, regulatory standards understanding (FDA, ICH, GMP, GLP, GCP)
Preferred skills
Process improvement, stakeholder influence, mentorship, cross-functional collaboration
Technologies
LMS, QMS, standard computer applications
Responsibilities
Independently perform complex quality system activities including document control, vendor management, audits, investigations, and product complaints; ensure accuracy and traceability of QA records; support electronic quality systems implementation and user support; review and process controlled documents and SOPs; generate and analyze quality metrics and dashboards; support inspection and audit readiness activities; identify and escalate compliance issues; lead process improvement efforts; provide guidance and mentorship to junior team members
Seniority
Senior, hands-on IC with mentorship responsibilities