Quality Compliance Specialist (Change Controls)
Core
Ensure quality and compliance with cGMPs and regulatory requirements for internal change control activities in a biotech/pharmaceutical setting.
Role type
Quality Compliance Specialist (Change Controls)
Builds
Change control documentation and processes
Domain
Biotechnology / Pharmaceuticals / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, FDA regulations, ICH guidelines, global regulatory standards, process analysis, documentation interpretation, cross-functional facilitation, MS Office proficiency
Preferred skills
Veeva/QMS experience
Responsibilities
Review and approve change control documentation, facilitate cross-functional meetings, partner with colleagues to implement continuous improvements, interpret regulatory requirements into procedures, support regulatory audits
Seniority
Mid-level IC (2+ years experience)