Sr Director, R&D Quality
Gilead Sciences
June 24, 2026
Remote friendly (United States)
United States
Operations
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 portfolio to identify risks, assess quality health, and guide mitigation/improvement prioritization.
- Lead analysis and interpretation of Quality data for reporting to functional and executive leadership.
- Manage critical/complex quality events and assess serious breaches.
- Develop action plans to address Quality and compliance risks.
- Lead Quality activities supporting product submissions and Health Authority responses.
- Establish partnerships with Clinical Development, Clinical Operations, Regulatory Operations, Safety, and Clinical Data Sciences.
- Generate clear, actionable insights to strengthen Audit and Inspection Management programs.
- Drive Quality by Design principles in therapeutic area development programs.
- Collaborate with therapeutic area leadership (Regulatory, Safety, Clinical Development, Clinical Operations).
- Drive risk-based decision making with clear rationale.
- Participate/provide expertise in licensing and collaboration activities.
- Support inspection preparation readiness across the program lifecycle.
- Identify and drive continuous quality process improvements using audit/inspection/event outcomes and trends.
- Provide guidance and training on relevant GxP regulations and guidelines.
- Serve as an expert on global GCP regulations and Gilead standards.
- Interface with external Quality organizations for development partners/collaborations.
- Support R&D Quality goals, including resource/outputs and line management oversight.
- Supervise, develop, train, and manage internal staff; lead intra/interdepartmental continuous improvement teams.
Qualifications:
- Bachelor’s (12+ years) / Master’s (10+ years) / 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 organization required.
- Preferred: familiarity with GVP and 21 CFR Part 11 electronic systems.
- Required: experience managing therapeutic area/disease-specific compliance programs.
- Required: Quality Risk Management (ICH Q9, ICH E6 R3).
- Required: lead business process improvement projects.
- Strong verbal/written/interpersonal skills; deliver executive presentations.
- Recognized expert on compliance topics; management of junior/senior staff.
- Proficient in Microsoft Office suite.
- Strongly preferred: Inspection/Audit management and/or CAPA management programs.
- Excellent organizational/project management; lead/mentor cross-functional teams.
- Ability to travel ~20%.
- 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 portfolio to identify risks, assess quality health, and guide mitigation/improvement prioritization.
- Lead analysis and interpretation of Quality data for reporting to functional and executive leadership.
- Manage critical/complex quality events and assess serious breaches.
- Develop action plans to address Quality and compliance risks.
- Lead Quality activities supporting product submissions and Health Authority responses.
- Establish partnerships with Clinical Development, Clinical Operations, Regulatory Operations, Safety, and Clinical Data Sciences.
- Generate clear, actionable insights to strengthen Audit and Inspection Management programs.
- Drive Quality by Design principles in therapeutic area development programs.
- Collaborate with therapeutic area leadership (Regulatory, Safety, Clinical Development, Clinical Operations).
- Drive risk-based decision making with clear rationale.
- Participate/provide expertise in licensing and collaboration activities.
- Support inspection preparation readiness across the program lifecycle.
- Identify and drive continuous quality process improvements using audit/inspection/event outcomes and trends.
- Provide guidance and training on relevant GxP regulations and guidelines.
- Serve as an expert on global GCP regulations and Gilead standards.
- Interface with external Quality organizations for development partners/collaborations.
- Support R&D Quality goals, including resource/outputs and line management oversight.
- Supervise, develop, train, and manage internal staff; lead intra/interdepartmental continuous improvement teams.
Qualifications:
- Bachelor’s (12+ years) / Master’s (10+ years) / 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 organization required.
- Preferred: familiarity with GVP and 21 CFR Part 11 electronic systems.
- Required: experience managing therapeutic area/disease-specific compliance programs.
- Required: Quality Risk Management (ICH Q9, ICH E6 R3).
- Required: lead business process improvement projects.
- Strong verbal/written/interpersonal skills; deliver executive presentations.
- Recognized expert on compliance topics; management of junior/senior staff.
- Proficient in Microsoft Office suite.
- Strongly preferred: Inspection/Audit management and/or CAPA management programs.
- Excellent organizational/project management; lead/mentor cross-functional teams.
- Ability to travel ~20%.