Assoc 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 an Associate Director Vendor Quality Management (VQM) to join our high-performing team that supports Clinical Development Pharmacovigilance & Medical Affairs 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 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 Gileads 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 Gileads 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 iregulatory 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:

• 10 Years with BS/BA
  OR
• 8 Years with MS/MA or MBA
  

Preferred Qualifications:

• Bachelors degree with 12 years; Masters degree with 10 years of R&D Quality assurance compliance experience in a highly regulated environment.
• Must have Clinical and pharmacovigilance audit and compliance experience
• Proven experience in managing vendor quality programs and/or vendor relationship management for clinical development Pharmacovigilance and medical affairs vendors
• Has effectively operated within Clinical Quality Assurance or similar function in a Biopharma sponsor organization
• Has experience advising business functions in the biopharma industry on quality and compliance
• Strong relationship building skills and ability to influence and negotiate with cross-functional stakeholders
• Effective verbal written interpersonal skills to include delivering presentations to executives
• Strong organizational & project management skills including the ability to prioritize and adapt to business needs while upholding compliance with regulations and company procedures.
• Able to maintain a balance between being strategic and taking deeper tactical dives as needed
• Excellent task and time management skills (e.g. project planning prioritization)
• Ability to travel up to 20% Preferred
• Understanding of principles for Quality Risk Management (ICH Q9 ICH E6 R3)
• Track record of successfully leading complex large scale time sensitive projects
• Experience in developing KQIs and monitoring compliance and trends
• Experience with Veeva Quality modules

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.

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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