Principal Quality Compliance Specialist, CVRM (Holly Springs)
Core
Lead strategic quality and compliance initiatives to embed a robust, risk-based Quality Management System (QMS) and drive operational excellence for aseptic drug product manufacturing.
Role type
Principal Quality Compliance Specialist (Strategic IC)
Builds
A state-of-the-art facility for high-volume, highly-efficient Drug Product manufacturing
Domain
Pharmaceutical manufacturing (Cardiovascular, Renal, and Metabolism medicines)
Required skills
Global GxP regulations, Risk-based Quality Management System (QMS), Data Integrity, QRM methodologies, Regulatory inspections, Cross-functional leadership, Lean/Six Sigma
Preferred skills
Annex 4 and Annex 11 compliance, Artificial Intelligence (Annex 22) controls, Digital compliance, Sterile manufacturing
Technologies
Digital tools, Real-time data analytics, Robotics, Automation
Responsibilities
Lead strategic Global Quality projects and translate network mandates into actionable plans; Serve as site SME for digital regulatory requirements and inspection commitments; Coordinate deep-dive assessments and complex risk assessments; Partner cross-functionally to harmonize standards and drive transformation; Mentor teams to enhance self-identification of risks; Support key compliance processes including recalls, self-inspections, and supplier management.
Seniority
Principal, strategic project leader & SME
