Principal QA Specialist
Core
Serve as a Quality Systems Subject Matter Expert overseeing Change Control governance, compliance, and continuous improvement for a pharmaceutical company.
Role type
Principal QA Specialist (Quality Systems)
Builds
Quality System processes and compliance frameworks for life-changing medicines
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
client delivery
Required skills
Change Control governance, Deviation management, CAPA management, Audit management, Risk Management, cGMP knowledge, regulatory compliance, data integrity, process improvement, cross-functional collaboration
Preferred skills
Leading governance forums, supporting regulatory inspections, developing Quality System procedures
Technologies
None stated
Responsibilities
Oversee Change Control governance and continuous improvement; Provide quality and compliance oversight of Quality System processes; Review and approve Quality System documentation; Lead or support governance forums and review boards; Monitor and analyze Quality System performance metrics; Perform quality review of complex cross-functional changes; Support regulatory inspections and customer audits; Identify compliance risks and lead corrective actions; Collaborate with Manufacturing, QC, Engineering, and other functions; Lead continuous improvement initiatives.
Seniority
Principal, hands-on IC with strategic oversight
