Associate Director, Quality Assurance, New Acquisitions

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.

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.  As an Associate Director Quality Assurance at Gilead, you will be a member of the API/OSD/Packaging group. This role is responsible for supporting initial integration of new asset acquisitions into Gilead systems. The role acts as a leader providing hands-on support as well as giving guidance to other QA staff to ensure new product assets are available quickly and compliantly.

Acts as the overall responsible QA person for transition of small and large molecule Due Diligence assets to active Gilead programs. May be the QA lead on Due Diligence projects and ensures high performance and consistency among other Due Diligence QA leads. This role may have direct reports but will also provide leadership for staff from other QA teams supporting newly acquired assets. Works closely with Product Strategy Team leads to ensure adequate QA coverage on new assets and to ensure onboarding and integration strategy is defendable. Supports QA staff on Due Diligence teams and new asset Product Strategy teams to assess and highlight risks and ensure proper communication of risks and proposed mitigations. Responsible for providing guidance on interpretation and application of existing and new US requirements pertaining to clinical and commercial phase programs. Manage or provide support for QMS records such as deviations (internal & external), CAPAs & Change Controls related to onboarding and integration activities. Participate in developing/approving Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met. Participate in the development & delivery of training programs relevant to Due Diligence and onboarding. Conduct/participate in gap analyses and risk assessments of processes & procedures against relevant guidelines as well as corporate standards. Participate in, or where relevant lead, local and corporate projects, and process improvement initiatives, as required. Knowledge, Experience & Behaviors: 10+ years of relevant experience in the pharmaceutical industry and a BS or BA OR 8+ years of relevant experience in the pharmaceutical industry and a MS OR 5+ years of relevant experience in the pharmaceutical industry and a PhD Deep knowledge and experience in quality assurance in a highly regulated manufacturing