Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Role: Clinical Compliance/Inspection Readiness Manager responsible for ensuring clinical trial activities meet regulatory standards and are prepared for inspections. Responsibilities include developing and delivering GCP and inspection readiness training, supporting audit and inspection preparations, managing inspection responses and CAPAs, and maintaining compliance documentation and metrics. The role also involves collaborating with QA on compliance assessments, conducting training on SOPs, and supporting continuous improvement in clinical practices. Requirements: BA/BS in a science-related field; 8+ years in biotech/pharma or CRO, with experience in compliance, quality, or clinical operations; expertise in global regulatory requirements (US CFR, EU CTD, ICH GCP); strong presentation, communication, and project management skills; experience with clinical audit and inspection processes preferred. High-Value: 8+ years in clinical operations within biotech or CRO, clinical compliance, GCP training, inspection readiness, audit and CAPA management, global regulatory knowledge, and experience supporting inspections. Work Setup: Onsite in Gaithersburg, MD or Conshohocken, PA; up to 20% travel.