Sr Director, R&D Quality

Job Description

Senior Director, Inflammation Therapeutic Area (TA) Lead R&D Program Quality – Foster City, CA

As the Senior Director, Inflammation TA Lead you will drive the strategy for a global team that provides GCP quality oversight for Inflammation products in the Gilead Development portfolio. By serving as trusted business partners, you and your team will collaborate closely with R&D functions to apply deep GCP expertise and a proactive, risk‑based mindset that accelerates confident decision‑making. In this role, you will be a key contributor to the R&D Quality Extended Leadership Team, championing a strong culture of Quality and elevating excellence across Gilead’s development.

• Design and implement the Quality Strategy for the Inflammation TA.
• Lead and direct Quality assessments across the Inflammation portfolio, conducting comprehensive evaluations that identify risks, assess overall quality health, and guide prioritization of mitigation and improvement efforts.
• Lead the analysis and interpretation of Quality data for the presentation and reporting to functional and executive leadership.
• Lead and supervise the management of critical and/or complex quality events as well as the assessment of serious breaches, for the Inflammation TA.
• Ensure the development of robust, comprehensive action plans that proactively address Quality and compliance risks.
• Lead Quality activities to support product submissions and responses to Health Authorities.
• Establish strong partnership with key functional leaders, including Clinical Development, Clinical Operations, Regulatory Operations, Safety and Clinical Data Sciences.
• Generate clear and actionable insights that strengthen the Audit and Inspection Management programs, ensuring oversight activities are focused where they matter most.
• Drive implementation of Quality by Design principles in Inflammation development programs.
• Collaborate with Virology and Oncology TA Leads aligning cross TA risks and the staff resourcing strategy.
• Drive risk-based decision making by delivering clear, insightful rationale that reflects sound judgement and deep Quality expertise.
• Participate/provide expertise in licensing and collaboration activities as applicable.
• Support management of internal inspection preparation activities and overall readiness throughout program life cycle for Gilead study teams.
• Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
• Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
• Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders.
• Interface with key external Quality organizations for Gilead development partners and collaborations.
• Support overall R&D Quality goals and objectives including but not limited to resource budget and outputs, and line management oversight of the team.
• Supervise, develop, train and manage internal staff. This includes fostering a commitment to quality in individuals and a culture of quality within the organization.
• Lead intra or interdepartmental teams such as continuous improvement initiatives.

• Bachelor’s degree with 12+ years;
  Master’s degree with 10+ years; or PhD with 8+ years of R&D.
• Must have broad GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience in a Bio‑pharma sponsor organization required.
• Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred.
• Track record of experience in managing therapeutic area and/or disease specific compliance programs required.
• Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R3) required.
• Experience leading business process improvement projects required.
• Proven effective verbal, written, interpersonal skills to include delivering presentations to executives.
• Recognized as an expert resource on a range of compliance topics.
• Management of junior and senior staff.
• Proficient in Microsoft Office suite.
• Experience…