Senior Director, Inspection Readiness

Role: Senior Director, Inspection Readiness - a senior clinical operations leader ensuring GCP compliance and operational excellence across Absci's clinical development pipeline. Responsibilities: develop and implement scalable inspection readiness frameworks, proactively assess clinical trial processes and documentation, manage risk mitigation, oversee regulatory reporting (e.g., ClinicalTrials.gov), and support inspection and audit preparations. Partner with functions including Quality, Regulatory, Data Management, and Clinical Development to close gaps, maintain inspection-ready TMFs, and embed a culture of quality and compliance. Qualifications: 15+ years in clinical operations or related drug development, with extensive experience in global trial execution, inspection support, and GCP standards. Deep knowledge of ICH-GCP, sponsor responsibilities, and regulatory inspection expectations. Skilled in SOP development, vendor oversight, and cross-functional collaboration, with strong leadership, communication, and strategic influence skills. High-value: focus on clinical trial compliance, inspection readiness, GCP, regulatory filings, and sponsor oversight in a biotech setting. Work setup: Hybrid, with up to 30% domestic and international travel.