Quality Compliance Lead
Core
Lead site compliance with FDA regulations, cGMP, and Quality Management Systems to ensure World Class Quality performance and drive inspection readiness.
Role type
Senior IC Quality Compliance Lead
Builds
FDA/BRC compliant manufacturing site operations and quality systems
Domain
Pharmaceutical/OTC manufacturing and regulatory compliance
Required skills
FDA cGMP knowledge, CAPA management, validation oversight, data integrity, root cause analysis, audit coordination, change management, statistical analysis (SPC/Capability)
Preferred skills
Biology/Chemistry/Engineering/Food Science/Microbiology degree, FDA-regulated OTC drug/pharmaceutical experience, advanced statistical tools proficiency
Technologies
SPC, Capability analysis, electronic records management systems, computerized system validation tools
Responsibilities
Lead regulatory compliance program and oversee FDA/BRC audits; Manage CAPA tracking and effectiveness verification; Coordinate inspection readiness and mock inspections; Oversee deviation investigations and data integrity programs; Govern equipment integrity and validation programs; Monitor maintenance and calibration compliance; Report compliance metrics and risks to leadership; Partner with cross-functional teams for continuous improvement.
Seniority
Senior, hands-on IC
