Audit Manager
Core
Lead internal and external GMP and Quality audit programs, ensuring regulatory compliance and product quality in a cGMP-regulated environment.
Role type
Senior IC Audit Manager (Quality & Compliance)
Builds
Audit readiness, compliance frameworks, and inspection responses for highly regulated manufacturing environments
Domain
Life Sciences / Biopharmaceuticals / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP audit leadership, FDA/ISO regulatory knowledge, CAPA management, cross-functional risk identification, audit logistics coordination, data integrity principles
Preferred skills
cGMP biopharmaceutical manufacturing expertise, regulatory agency inspection hosting, audit readiness program development
Technologies
FDA 21 CFR Part 210/211, ISO 13485, ICH Q10, cGMP
Responsibilities
Lead audit planning, execution, and closeout; maintain knowledge of FDA inspectional trends; coordinate audit logistics and readiness; partner with teams to identify compliance risks and develop CAPA
Seniority
Senior, hands-on IC