Sr Director, R&D Quality

Senior Director – Therapeutic Area (TA) Lead (R&D Portfolio Quality) Responsibilities Design and implement the Quality Strategy for Oncology, Virology and Inflammation therapeutic areas across the development lifecycle. Lead and direct Quality assessments across early and late phase portfolios; identify risks, assess quality health, and guide mitigation/improvement prioritization. Analyze and interpret Quality data for functional and executive reporting. Manage critical/complex quality events and assess serious breaches. Develop action plans to address Quality and compliance risks. Lead Quality activities to support product submissions and Health Authority responses. Establish partnerships with Clinical Development, Clinical Operations, Regulatory Operations, Safety, and Clinical Data Sciences. Generate actionable insights to strengthen Audit and Inspection Management. Implement Quality by Design principles. Collaborate with cross-functional therapeutic area leadership. Drive risk-based decision-making with clear rationale. Provide expertise for licensing and collaboration activities. Support internal inspection preparation and program readiness. Identify and drive continuous quality process improvements via audits/inspections/events and trend analysis. Provide guidance and training on relevant GxP regulations and global GCP regulations/Gilead standards. Interface with external Quality organizations for development partners. Support R&D Quality goals/objectives and line management oversight. Supervise, develop, train, and manage internal staff; lead improvement initiatives. Qualifications Bachelor’s degree +12+ years; Master’s +10+ years; or PhD +8+ years in R&D (quality assurance/compliance experience). Broad GCP audit and compliance experience; Clinical Quality Assurance/Compliance in a bio-pharma sponsor required. Quality by Risk Management experience (ICH Q9, ICH E6 R3) required. Experience leading business process improvement projects required. Familiarity with GVP and 21 CFR Part 11 preferred. Track record managing therapeutic area/disease-specific compliance programs required. Strong communication skills; recognized expert; management experience. Proficient in Microsoft Office; inspection/audit/CAPA management experience strongly preferred. Excellent organizational/project management; can lead/mentor cross-functional teams. Travel ~20%. #J-18808-Ljbffr Scorpion Therapeutics