Principal Quality Compliance Specialist, CVRM (Holly Springs)
Core
Lead strategic quality and compliance initiatives for a new greenfield drug manufacturing facility, embedding a risk-based Quality Management System and ensuring global regulatory adherence.
Role type
Principal Quality Compliance Specialist (Strategic IC)
Builds
A state-of-the-art aseptic drug product manufacturing plant for next-generation metabolic medicines.
Domain
Pharmaceutical manufacturing (Cardiovascular, Renal, Metabolism) / GxP Compliance / Digital Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic project execution, Risk-based Quality Management System (QMS) design, Global GxP regulations (FDA, EMA, ICH, ISO), Annex 4 & 11 compliance, Data Integrity, QRM methodologies, Cross-functional leadership, Regulatory inspection management
Preferred skills
Artificial Intelligence governance (Annex 22), Lean/Six Sigma, Sterile manufacturing expertise, Digital compliance transformation
Technologies
Digital tools, Real-time data analytics, Automated robotics systems
Responsibilities
Lead strategic global quality projects and translate network mandates into local action plans; Serve as site SME for digital regulatory requirements and inspection commitments; Coordinate deep-dive assessments and complex risk evaluations; Partner cross-functionally to harmonize standards and drive operational transformation; Mentor teams to foster a proactive risk-based quality culture; Support key compliance processes including recalls, self-inspections, and supplier management.
Seniority
Principal, strategic leadership & hands-on execution