Senior Director, Clinical Quality

Role: Senior Director of Quality Assurance overseeing clinical quality in biopharma, focusing on GCP and GPvP compliance across clinical development stages. Responsibilities: develop risk-based QA strategies, oversee audits of CROs and vendors, manage compliance risks, lead regulatory inspections, review clinical and regulatory documents, and foster a quality-centric culture. Requirements: Bachelor's in a scientific or related field with 12+ years in pharma/biotech, extensive GCP/GPvP knowledge, experience with audits, inspections, and regulatory submissions, and demonstrated leadership in clinical QA. Preferred: oncology experience, support for mid-to-late-phase trials, familiarity with Veeva and SharePoint, and ability to travel ~25%. HighValue: clinical-stage biotech, oncology focus, GCP, GPvP, GLP support, regulatory inspection readiness, vendor oversight, clinical documentation review, international travel. WorkSetup: remote USA.