Senior Director, Quality

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
 

The role will be accountable for QA operations in US, Canada & LATAM markets to ensure GMP & GDP compliance for Gilead products. This role will be directly responsible for developing QA strategies that strengthen & harmonize GDP compliance across the US, Canada & LATAM regions.

The Senior Director QA will sit on the GPD&A leadership team, who are responsible for the management and operational development of strategy for Gilead Quality Distribution & QA Operations within each market Gilead supply, and the individual is expected to actively participate in, and support the goals of this Leadership team. The role also requires someone with a track record of excellent people leadership & influencing skills, experience in developing & implementing strategic goals, as well as hands-on experience supporting multiple QA operating models across a global commercial network and delivering successful governance & QA operating processes.

The primary responsibilities include, but not limited to, the following: 

• Serve as a key member of the GPD&A Leadership Team, who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium- and long-term strategic plans for all regions, which supports the overall strategic plans for the quality organization.

• Coach and mentor direct reports to drive independence, development, and performance & provide leadership to ensure a safe, respectful, and inclusive work environment.

• Manage financial budget, resource and workload balance with team to ensure local QA activities are performed to meet timelines and quality & compliance expectations in an equitable manner as well as ensuring that key performance indicators are monitored and reported, and key project timelines & milestones are tracked. Provides guidance on prioritization when necessary.

• Act as Senior QA advisor to in-country & cluster (group of countries) QA leads with interpreting the local & regional regulatory requirements as they pertain to the distribution of Gilead products

• Act as senior liaison with Gilead’s distribution partners (in US, Canada & LATAM markets) related to escalations & critical/major issues, as well as with changes that impact Gilead’s business models with these partners

• Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies.

• Provide leadership for local market activities across US, Canada & LATAM regions supporting product recall and support periodic product recall challenges to ensure Gilead’s in-country distribution operations are in a state of continuous readiness in the event of needing to support product recall or other types of market action.

• Lead highly complex investigations, including development and implementation of corrective and preventative action (CAPA), as required.

• Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.

• Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies.

• Collaborate cross-functionally and geographically with key stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs, Global Trade Ops, Global Commercial Operation