Change Control Specialist
Core
Execute GMP change control processes for laboratory testing, ensuring regulatory compliance and operational effectiveness.
Role type
Senior Change Control Specialist (Pharmaceutical/Life Sciences)
Builds
Regulatory-compliant change management processes and quality assurance outcomes for analytical testing
Domain
Pharmaceutical/Biologics laboratory operations and Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, change control management, root cause analysis, technical writing, regulatory interpretation, cross-functional leadership, strategic process improvement
Preferred skills
Experience with new technologies and methodologies, mentoring technical teams
Technologies
GMP laboratory systems, quality management software, regulatory databases
Responsibilities
Execute GMP change control processes for laboratory testing; Lead cross-functional teams through change planning, implementation, and verification; Evaluate regulatory and technical impacts of proposed changes; Author and review technical reports and regulatory documentation; Lead root cause investigations for quality and compliance issues; Provide scientific leadership and mentoring to laboratory and quality personnel
Seniority
Senior, hands-on IC with strategic oversight