Assoc Director, Quality Assurance Compliance

Associate Director, Vendor Quality Management (VQM)

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.

R&D Quality is seeking an Associate Director, Vendor Quality Management (VQM) to join our high-performing team that supports Clinical Development, Pharmacovigilance & Medical Affairs programs at Gilead. In this role you will be responsible for providing quality advice, direction, and leadership for quality and compliance oversight of GxP vendors. You will partner closely with business functions in applying a risk-based approach to key vendor activities which include vendor risk assessments, qualification / requalification and issue escalation. You will work closely with external quality groups to ensure vendor commitments & services meet Gilead standards and comply with regulations. You will act as the Quality Business Partner to assigned groups, such as Gilead R&D functions and vendors supporting Gilead R&D. You will provide expert advice on GxP risk minimization and mitigation. You will identify support management of vendor risks within the Development organization. You will participate in and / or lead Vendor Quality forums, Quality Management Review, Functional Quality forums and projects through providing quality metrics and analyzing quality data to identify risks and areas of focus.

The VQM group within R&D Quality needs someone with strong leadership skills, expert knowledge of the regulations governing drug development. This role will focus on vendor oversight activities, is highly visible, requires strong relationship building skills and the ability to influence and negotiate with cross-functional stakeholders. Professionalism and the ability to represent Gilead's reputation externally is critically important. An understanding of Quality Risk Management (QRM) principles, experience managing people, as well as a track record of leading complex, cross functional process improvement projects is desirable. You will be a part of an expert global Quality team that strives to be a trusted business partner and promotes a culture of Quality in all we do.

Primary Responsibilities :

• Oversees comprehensive vendor quality oversight program which includes leading vendor risk assessments, Quality Issue Management for Pharmacovigilance and Medical Affairs vendors.
• Interfaces with key internal business stakeholders and external groups including Vendors and Contract Research Organizations (CROs) Quality organizations.
• Develops strong relationships with Gilead's key vendors, creating a mindset of partnership and mutual respect.
• Leads quality participation in vendor qualification, selection, requalification and quality management.
• Lead and support development and ongoing management of Quality Agreements and Quality to Quality (Q2Q) meeting charters with key vendors.
• Leads Quality-to-Quality governance meetings and represents R&D Quality in Operational Management committee (OMC) meetings for key vendors.
• Oversees effective vendor quality reporting to functional management and the Gilead Senior Leadership. This includes presenting relevant vendor quality metrics, trends and quality risks at quality meetings & governance forums.
• Reviews vendor contractual language from a quality & compliance perspective.
• Collaborates with the Audit team within R&D Quality on internal quality audits by providing risks and areas of focus for vendor audits.
• Provides support for regulatory inspections by functioning as the vendor liaison.
• Supports management of significant quality deviations and CAPAs for vendor related activities.
• Serves as an expert and provide guidance on and interpretation of GxP regulations, standards, and quality systems for internal stakeholders.
• Leads intra or interdepartmental teams as assigned, such as continuous improvement initiatives.
• Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.

Basic Qualifications :

Preferred Qualifications :

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.

People leader accountabilities

Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is : $165,495.00 - $214,170.00. 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.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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