Lead Quality Dossier Program Auditor
Core
Plan and conduct audits for clinical, pre-clinical, and CMC documents within the Quality Dossier Program to ensure regulatory compliance.
Role type
Senior Quality Assurance Auditor (Medical Device/Pharmaceutical)
Builds
Audit schedules, compliance reports, and resolution plans for quality issues.
Domain
Pharmaceutical/Medical Device Quality Assurance
Required skills
Quality Assurance auditing, regulatory compliance review, audit scheduling, stakeholder communication, peer review, problem resolution
Preferred skills
Medical Writing, Regulatory Affairs, Development Sciences collaboration
Technologies
None stated
Responsibilities
Plan and conduct audits of clinical, pre-clinical, and CMC documents; Perform peer reviews of document audits; Review audit responses for adequacy and compliance; Maintain audit schedule; Recommend plans of action for quality issues; Coordinate review and tracking of audit responses; Assist in Due Diligence and Post-Closure Quality Assessment activities.
Seniority
Senior, hands-on IC
