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%.

Application instructions: Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).