Senior Director, R&D Quality

This is a fully remote position, open to applicants in California.

📋 Description

• Develop and execute the Quality Strategy for the therapeutic areas of Oncology, Virology, and Inflammation throughout the development lifecycle.

• Oversee and lead Quality assessments across both early and late phase portfolios, conducting thorough evaluations that identify risks, assess overall quality health, and inform prioritization of mitigation and enhancement efforts.

• Direct the analysis and interpretation of Quality data for presentation and reporting to functional and executive leadership.

• Manage critical and/or complex quality events and assess serious breaches.

• Ensure the formulation of robust, comprehensive action plans that proactively tackle Quality and compliance risks.

• Lead Quality initiatives to support product submissions and responses to Health Authorities.

• Cultivate strong partnerships with key functional leaders, including those in Clinical Development, Clinical Operations, Regulatory Operations, Safety, and Clinical Data Sciences.

• Generate clear and actionable insights that enhance the Audit and Inspection Management programs, ensuring oversight activities are prioritized effectively.

• Propel the implementation of Quality by Design principles within therapeutic area development programs.

• Collaborate with therapeutic area leadership across functions, particularly in Regulatory, Safety, Clinical Development, and Clinical Operations.

• Foster risk-based decision-making by providing clear, insightful rationale that reflects sound judgment and extensive Quality expertise.

• Engage in and provide expertise for licensing and collaboration activities as appropriate.

• Assist in managing internal inspection preparation activities and overall readiness throughout the program lifecycle for Gilead study teams.

• Identify and spearhead continuous quality process improvements by assessing audit, inspection, and quality event outcomes, along with identifying trends from internal deviations.

• Offer guidance and training on pertinent GxP regulations and guidelines to cross-functional business partners.

• Act as an expert resource, providing 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 budgeting and outputs, as well as line management oversight of the team.

• Supervise, develop, train, and manage internal staff, promoting a commitment to quality and fostering a culture of quality within the organization.

⛳️ Requirements

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

• Extensive GCP audit and compliance experience is essential.

• Clinical Quality Assurance/Compliance experience within a Bio-pharma sponsor organization is required.

• Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred.

• Proven experience managing therapeutic area and/or disease-specific compliance programs is required.

• Experience in implementing Quality Risk Management principles (ICH Q9, ICH E6 R3) is necessary.

• Experience leading business process improvement projects is required.

• Strong verbal, written, and interpersonal skills, including the ability to present to executives effectively.

• Recognized as an expert resource on a variety of compliance topics.

• Experience managing junior and senior staff.

• Proficient in the Microsoft Office suite.

• Experience with Inspection and Audit management/CAPA management programs is strongly preferred.

• Excellent organizational and project management capabilities.

• Capable of leading and mentoring effective cross-functional teams.

🏝️ Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives.

• Paid time off.