Sr. Quality Assurance Specialist

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.  As a Senior Quality Assurance Specialist at Gilead you will have the following responsibilities:

• Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products. Responsible for final release of manufactured products. 

• Participates in introduction of new clinical/commercial products (e.g., small molecules and biologics) to the site. 

• Participates in risk assessments. 

• Participates in author, review, and approval of changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs). 

• Participates in site inspection readiness activities. 

• Participates in internal and external audits as needed. 

• Participates in continuous improvement initiatives. 

• Supports generation, and review of metrics and trending data. 

• Partner with internal partners to ensure resolution of quality issues.  

• Participates in review/approval of Deviations, CAPAs, and Change Management records as required. 

• Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Considerable judgement is required in resolving problems and making scientific routine recommendations. 

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. 

Requirements:  

• Bachelors Degree and 6+ years of experience required OR 

• Masters Degree and 4+ years of experience required OR 

• PhD or PharmD with 0+ years of experience

• Experience with parenteral and aseptic operations; proficiency or familiarity with Annex 1 requirements. 

• Experience across broad areas of Quality Assurance and/or Quality Systems. 

• Experience with interacting with regulatory agencies. 

• Excellent interpersonal, verbal, and written communication skills. 

• Knowledge of Risk Management tools (e.g., HACCP and FMEA) 

Preferred Qu