Sr Director, R&D Quality

Job: Senior Director Therapeutic Area (TA) Lead R&D Portfolio Quality 

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs? We are seeking a leader with bold, forward-looking mindset, someone who brings expert therapeutic area knowledge, a command of global regulatory expectations, and a mastery in applying quality risk management principles to complex development programs.   

As the Senior Director, Therapeutic Area Lead you will drive the strategy for a global team that provides GCP quality oversight for early and late phase Oncology, Virology and Inflammation therapeutic area products in the Gilead R&D 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  

You will join a dynamic, global R&D Quality organization dedicated to partnership, innovation, and the belief that Quality is not just a discipline, but in fact a strategic advantage that strengthens every study, every decision, and every outcome. Together, we drive a culture where Quality empowers progress and ensures we deliver for the patients we serve. 

Responsibilities 

• 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. 

• Leads intra or interdepartmental teams such as continuous improvement initiatives. 

Qualifications 

• 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. 

• Ability to travel <