Clinical Compliance Operations Specialist
Core
Facilitate and manage GCP project implementation audits to ensure internal adherence to Veeva processes and quality standards across regulated domains.
Role type
Clinical Compliance Operations Specialist (Quality Assurance)
Builds
GCP-compliant product implementations and validated systems for life sciences customers
Domain
Life Sciences / Clinical Research / Regulatory Compliance (GCP, HIPAA, CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP regulations knowledge, Quality Management Systems (QMS), Computer System Validation (CSV), CAPA program management, audit documentation, supplier assessment, technical writing, process improvement
Preferred skills
Veeva Development Cloud experience, clinical trials IT systems auditing, Agile methodology, Quality Auditor Certification (ASQ CQA or ISO 13485)
Responsibilities
Verify compliance to policies and regulations in GCP projects, perform GxP/Quality review of project deliverables, document audit findings and support remediation, author GxP records and audit reports, conduct incident/CAPA investigations, provide quality oversight on validation testing and product releases, perform supplier assessments
Seniority
Mid-level, hands-on IC
