Senior Director, Inflammation Therapeutic Area Lead, Clinical Quality Business Partner

Senior Director, Inflammation Therapeutic Area Lead, Clinical Quality Business Partner
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

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?

R&D Quality is seeking a Senior Director, Inflammation TA Lead to join our Clinical Quality Business Partners Leadership Team. In this role you will lead and set strategy for a global team that provides the GCP quality oversight for Inflammation products in development at Gilead.

Acting as trusted business partners you and your team will work closely with R&D functions in applying expert GCP knowledge and a risk-based approach that enable decision making. You will also be a key member of the R&D Quality Leadership Team advancing a culture of Quality across Gilead.

We seek an individual with strong leadership skills, expert therapeutic area knowledge, advanced understanding of the regulations governing drug development and 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.

Primary Responsibilities
Design and implement the Quality Strategy for the Inflammation TA.
Lead and direct assessment of Inflammation risk areas and provide these insights to the Quality Audit and Inspection Management programs in order to prioritize oversight activities and propose modifications where necessary.
Help drive implementation of Quality by Design principles in Inflammation development programs.
Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory Operations and Clinical Data Sciences.
Collaborate with Virology and Oncology Quality Leads aligning on cross TA risks and the staff resourcing strategy.
Provide risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks.
Lead the analysis and interpretation of key quality data for the presentation and reporting to functional and executive leadership.
Lead and supervise the management of critical and/or complex quality as well as the assessment of serious breaches for the Inflammation TA.
Lead Quality activities to support product submissions and responses to Health Authorities.
Participate/provide expertise in in licensing and collaboration activities as applicable.
Lead/oversee management of internal inspection readiness activities 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.
Proven experience in managing Inflammation compliance programs required.
Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R2) 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 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?

The salary range for this position is: $237, $307, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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