Sr. Clinical QA Manager
Core
Lead Clinical Quality Assurance (CQA) activities, manage GCP audits, and ensure regulatory compliance for research projects across multiple therapeutic areas.
Role type
Senior Clinical QA Manager
Builds
Compliance for clinical development and commercial products
Domain
Biopharmaceuticals / Neuroscience
Deliverable
client delivery
Required skills
GCP audit management, risk mitigation planning, regulatory compliance, SOP development, trend analysis, corrective action planning, site inspection preparation, GCP training, project management, leadership
Preferred skills
Gene therapy clinical trial experience, international GCP regulations knowledge
Technologies
Audit databases, tracking systems
Responsibilities
Lead and oversee GCP audits (vendor, site, internal), develop audit plans and resourcing, monitor regulatory status of investigators, provide guidance on remediation plans, lead site inspection preparations, develop and standardize quality systems and SOPs, conduct trend analyses of GCP metrics
Seniority
Senior, hands-on IC with leadership
