Superintendent, Compliance
Core
Leading a team of CAPA writers and investigators to improve quality system execution, prevent nonconformances, and ensure regulatory compliance for manufacturing operations.
Role type
Senior Manufacturing Compliance Superintendent
Builds
Quality systems, compliance strategies, and audit responses for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Regulatory compliance (cGMP, ICH), CAPA management, risk assessment, team leadership, audit response, trend analysis, procedure design
Preferred skills
Electronic document management systems, regulatory inspection experience, mentoring, cross-functional collaboration
Technologies
TW8, quality management software tools
Responsibilities
Ensure timely initiation and completion of nonconformance and exception records; design and deliver updates to procedures and controls; conduct risk assessments and establish trend reviews; interface with auditors and oversee investigations; analyze performance indicators; support audit responses.
Seniority
Senior, hands-on IC with people management
