Sr Director, R&D Quality

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

R&D Quality is seeking a Senior Director Quality Operations Excellence Lead to join our R&D Program Quality this role you will lead and set a strategy for ensuring the execution of Quality Oversight activities for all products in development at Gilead. Through the establishment of standards and promoting best practices you will drive optimized performance for key focus areas critical to the success of R&D Quality.

Acting as trusted business partners you and your team will work closely with R&D Program Therapeutic Area Leads to oversee the consistent performance and outputs of key activities such as study oversight plans critical quality event management serious breach assessments study/program/therapeutic area analytics and Quality Briefs. Reporting to the Executive Director R&D Program Quality you will also be a key member of the R&D Quality and Medical Governance Extended Leadership Team advancing a culture of Quality across Gilead.

We seek an individual with strong leadership skills expert drug development and GCP knowledge and advanced understanding of the application of Quality Risk Management principles.

You will be a part of a dynamic global Quality leadership team that strives to be a trusted business partner and promotes a culture of Quality in all we do.

Job Responsibilities

• Design and implement an integrated Quality Operations Strategy for the Gilead R&D portfolio.
• Establish standards tools & performance indicators for key activities including quarterly metrics & risk reporting for Program/Study Quality Briefs Due Diligence Quality Oversight Plans critical quality event management serious breach assessment and reporting.
• Lead the analysis and interpretation of key quality data in Program/Study Quality Briefs for the presentation and reporting to functional and executive leadership.
• Lead and oversee lessons learned activities driving continuous improvement.
• Optimize R&D Program Quality performance by implementing a flexible centralized resourcing model for high-demand activities.
• Oversee and lead critical quality event investigations and serious breach assessments.
• Act as point of contact (PoC) for due diligence activities ensuring collaboration with Regulatory and Safety leads.
• Collaborate with Oncology Virology and Inflammation Program Leads in assessing cross therapeutic area risks.
• Act as PoC for Program Quality for key initiatives within Global R&D Quality and RSQ.
• Providing guidance and training for core quality management capabilities such as risk management quality event management and issue escalation and deviation and CAPA management.
• Establish strong partnership with key business stakeholders including Clinical Development Clinical Operations Regulatory Safety and Clinical Data Sciences.
• Identify and drive continuous quality process improvements through assessment of audit inspection and quality event outcomes and identification of trends from internal deviations.
• Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders.
• Supports overall R&D Quality goals and objectives including but not limited to Quality strategy & goals.
• Supervise develop train and manage internal staff as needed. This includes fostering a commitment to quality in individuals and a culture of quality within the organization.
• Leads intra or interdepartmental teams such as goal and continuous improvement initiatives.

Qualifications

• Bachelors degree with 12 years; Masters degree with 10 years; or PhD with 8 years of R&D quality assurance compliance experience
• Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required.
• Proven experience in managing compliance programs required.
• Experience in implementing principles for Quality Risk Management (ICH Q9 ICH E6 R3) required
• Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred.
• 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 is approximately 20% required.

About Gilead R&D Quality

Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.

We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science discovery and creative thinking into

everything we do. We are an inclusive and diverse community who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills experience and your career.

Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world

Ready to create possible together Hit apply.

This is a hybrid (3 days per week) role is base in Foster City

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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