Senior Manager, Inspection Readiness - GCP

Role: Senior Manager, Inspection Readiness supporting Clinical Trial Operations by ensuring clinical compliance and preparing for inspections, with a focus on GCP adherence and process improvement. Responsibilities: design and optimize inspection readiness tools and processes, guide study teams on GCP compliance, lead risk assessments and metrics analysis, develop inspection readiness training, collaborate with QA for inspection activities, oversee quality events, and support regulatory compliance efforts. Requirements: MSc in Life Sciences, Pharmacy, Medicine, or related; 8+ years in Clinical Operations, Quality, or Compliance within biopharma; deep understanding of clinical trial processes, ICH-GCP, and global regulatory standards (FDA, EMA, etc.); project management experience and stakeholder collaboration skills; excellent communication abilities. Preferred Qualifications: experience mentoring teams, process enhancement initiatives, and working within complex, global, matrix organizations. High-Value: clinical trial compliance, inspection readiness, GCP, regulatory standards, quality oversight, and process optimization in a biotech or pharmaceutical setting.