Senior Director, R&D Quality

Role Overview

• Design and implement the Quality Strategy for Oncology, Virology and Inflammation therapeutic areas across the development lifecycle.
• Lead and direct Quality assessments across the early and late phase 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.
• 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, ensuing oversight activities are focused where they matter most.
• Drive implementation of Quality by Design principles in therapeutic area development programs.
• Collaborate with cross function therapeutic area leadership, in particular Regulatory, Safety, Clinical Development and Clinical Operations.
• Drive risk-based decision making by delivering clear, insightful rationale that reflect sound judgement and deep Quality expertise.
• Participate/provide expertise in 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.
• Supports 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.

Requirements

• Bachelor’s degree with 12+ years; Master’s degree with 10+ years; or PhD with 8+ years of R&D quality assurance compliance experience
• 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 with Inspection and Audit management/CAPA management programs strongly preferred.
• Excellent organizational and project management skills.
• Able to lead and mentor effective cross functional teams.

Tech Stack

• Google Cloud Platform

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives
• paid time off