Senior Quality Compliance Specialist, CVRM (Holly Springs)
Core
Senior Quality Compliance Specialist responsible for designing and implementing Quality Risk Management (QRM), Data Integrity, and Change Control programs to ensure global regulatory compliance in a new sterile drug manufacturing facility.
Role type
Senior Quality Compliance Specialist (GxP Manufacturing)
Builds
A state-of-the-art sterile drug product manufacturing facility for next-generation metabolic medicines.
Domain
Pharmaceutical manufacturing (sterile drug products) and Quality Compliance
Required skills
Quality Risk Management (QRM), Data Integrity, Change Control, GxP regulations, risk-based decision-making, cross-functional leadership, regulatory inspection management
Preferred skills
Advanced degree, broad Quality/Operations experience, digital manufacturing landscape expertise
Technologies
FMEA, PHA, automated/digital systems
Responsibilities
Facilitate complex risk assessments and translate risk-based data into operational controls; take ownership of the site Data Integrity program and cultural integration; chair the Change Review Board for high-impact modifications; oversee core quality systems including inspections, recalls, and supplier management.
Seniority
Senior, hands-on IC