Sr Director, R&D Quality

Role Summary

Senior Director, Inflammation TA Lead, R&D Program Quality, Foster City, CA. Drives the strategy for a global team providing GCP quality oversight for Inflammation products in the Gilead Development portfolio. Partners with R&D functions to apply deep GCP expertise and a proactive, risk-based mindset that accelerates confident decision-making. A key contributor to the R&D Quality Extended Leadership Team, championing a strong culture of Quality across development to deliver better outcomes for patients.

Responsibilities

• Design and implement the Quality Strategy for the Inflammation TA.
• Lead and direct Quality assessments across the Inflammation portfolio, conducting 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 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 partnerships with 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 reflect sound judgement and deep Quality expertise.
• Participate 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 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; foster a commitment to quality and a culture of quality within the organization.
• Lead intra- or interdepartmental teams such as continuous improvement initiatives.

Qualifications

• Broad GCP audit and compliance experience; Clinical Quality Assurance/Compliance experience in a bio-pharma sponsor organization.
• Experience implementing Quality Risk Management (ICH Q9) and ICH E6 R3 principles.
• Track record of experience in managing therapeutic area and/or disease-specific compliance programs.
• Must have strong verbal, written, interpersonal skills and the ability to present to executives.
• Recognized as an expert resource on a range of compliance topics.
• Management of junior and senior staff; ability to lead cross-functional teams.
• Proficient in Microsoft Office suite.
• Experience with Inspection and CAPA management programs (strongly preferred).
• Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities (preferred).
• Excellent organizational and project management skills.

Education

• Bachelor’s degree with 12+ years; Master’s degree with 10+ years; or PhD with 8+ years of R&D quality/compliance experience.

Skills

• GCP/GxP regulatory knowledge and quality management systems.
• Audit and inspection management; CAPA processes.
• Quality by Design (QbD) principles.
• Cross-functional collaboration and stakeholder management.
• Data analysis, interpretation, and reporting to leadership.
• Leadership, mentoring, and people management.
• Microsoft Office proficiency.

Additional Requirements

• Ability to travel approximately 20%.