Senior Quality Compliance Specialist, CVRM (Holly Springs)
Core
Design and implement Quality Risk Management (QRM) and Data Integrity programs for a new sterile drug product manufacturing facility, ensuring compliance with global GxP regulations.
Role type
Senior Quality Compliance Specialist (Manufacturing)
Builds
A state-of-the-art aseptic drug product manufacturing plant for cardiovascular, renal, and metabolism medicines.
Domain
Pharmaceutical manufacturing, sterile drug production, regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Risk Management (QRM) methodologies (FMEA, PHA), Data Integrity program ownership, Change Control leadership, GxP regulatory knowledge (FDA, EMA, ICH, ISO), risk-based decision-making, cross-functional collaboration
Preferred skills
Advanced degree in scientific/technical discipline, experience in highly automated/digital facilities, broad Quality and operations experience, regulatory inspection experience
Technologies
FMEA, PHA, digital manufacturing systems, automated analytical systems
Responsibilities
Facilitate complex risk assessments and translate risk data into operational controls; Lead Data Integrity assessments and establish cultural programs; Chair Change Review Board for high-impact modifications; Provide oversight of core quality systems and support compliance processes (recalls, inspections, supplier management); Engage with global stakeholders on compliance trends.
Seniority
Senior, hands-on IC
