Example Experience: Minimum of fifteen (15) years of experience as a Quality and/or Compliance professional working in the FDA, regulated industry (i.e. Medical Device, Pharmaceutical, Biotechnology, etc.) or as a Consultant. Masters or Doctorate level of education, or equivalent experience preferred. Must be proficient in writing and presentations skills. The ability to travel both domestic and internationally is a major aspect of the role.
Example Responsibilities: Lead Auditor, Subject Matter Expert, Coach and Trainer in a FDA regulated environment. Work solo or on teams providing strategic consultation and/or performing remediation following FDA Compliance Actions (FDA-483s and Warning Letters). Team Lead and/or Project Manager/Leader on large or complex projects with multiple work streams (includes the management of resources). Must have the ability to audit and assess Device Quality System and/or Drug GMPs to ensure compliance with FDA Requirements.
Technical Experience: Experience in conducting, managing, and leading internal/external audits, which may include QSR and/or cGMP audits. Experience in the area of FDA Inspection Preparation, subject matter expert for FDA inspections, and developing responses to FDA-483 observations.
Experience as Subject Matter Expert (SME) in more than one of the following areas: Complaint Handling and Post Market Reporting, Production & Process Controls (including Process Validation), Design Controls, Risk Management, CAPA, Computer System Validation,, Purchasing & Supplier Controls, Management Controls, etc..
In-depth knowledge and experience working with 21 CFR Parts 4, 820, 210/211, 803, 806, as well as ISO 13485, 14971 and related International Requirements.