Associate Director, Quality Assurance Compliance

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
 

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. 

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.  

We prefer a candidate that is site-based (local to Foster City). You will be on site Tuesday, Wednesday, Thursday. For non-local talent, we are open to remote.

As an Associate Director, Quality Assurance Compliance at Gilead you will have the following responsibilities:

Inspection Operation and Logistics (Foster City):

• Manages the logistics to support regulatory inspections at GSI Foster City including notification process, inspection support team (IST), prep room and inspection rooms and post-inspection activities

• Build inspection readiness tools, templates and training materials for perpetual readiness for GSI FC – including inspection system training, inspection support team (host, scribe, request champion, SMEs, Facilities, IT etc.)

• Provide logistics support for partner audits including training, inspection coordination and prep room support.

• Management of all inspection related documentation including document retention and tracking (pre-inspection notification, documents reviewed/retained/requested by investigator/agency)

• Management of post-inspection activities including upload of inspection documents in GVault; coordination and assessment of inspection observation response from key stakeholders, maintenance of evidence binder and coordination of the inspection readiness of the evidence binders and/or storyboards

• Management of inspection systems utilized to support inspections including guides, tools, troubleshooting and training (i.e. MSTeams, Sharepoint, Zoom)

• Coordinate site inspection logistics with the different cross functional groups including general notification, investigator needs, conference room set-up (printers, boards, zoom, phones, office supplies, laptops, iPad/cart for virtual tours) and inspection support team assignment and schedule 

• Develop and maintenance of Inspection Readiness MSTeams/SharePoint as a centralized resource for inspection readiness support and resources for FC PDM Organization

General and PAI Readiness (Foster City and Global):

• Responsible for the management and maintenance of regulatory inspection procedures and documentation including Regulatory Inspection Policy, Site Master File, Opening Presentation and other related procedures

• Lead PAI readiness activities by partnering with project teams to evaluate inspection readiness of the team including coordination of a mock inspection as needed

• Lead periodic inspection readiness activities for GSI FC including annual mock inspection, inspection logistics drill, inspection readiness meeting with different function areas that will support and participate during an inspection (Management, Inspection Support Team, Security, Administrative Assistance, Facilities and IT)

• Lead global inspection readiness activities and meetings to share best practices and collaborate on inspection readiness topics and projects; identify and drive improvements

• May support mock PAI inspections as part of audit team

• Oversees