Assoc Director, Quality Assurance Compliance

Assoc Director, Quality Assurance Compliance

United States - New Jersey - Parsippany

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

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  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.
• Leads 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,…