Sr Director, R&D Quality

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Responsibilities

·        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, ensuing 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/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 proce