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.

• 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%.