About Gilead

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 Responsibilities

• Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC
• Certifies batches for sale or supply in compliance with regulations
• Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations)
• Attends and participates Event Review, Quality Systems Review and Site QP Meetings
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
• Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products
• Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis to enforce requirements and meet specifications
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products
• Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes
• May assist or lead compliance audits as required
• May interface with regulatory agencies as required
• Interfaces with contract manufacturers to address documentation and compliance issues

Required Knowledge

• Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• Proficient in application of QA principles, concepts, industry practices, and standards
• Demonstrates ability to effectively manage multiple projects/priorities
• Proven analytical and conceptual skills
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
• Demonstrates excellent verbal communication, technical writing and interpersonal skills
• Demonstrates working knowledge with good proficiency in Microsoft Office applications

Beneficial Knowledge

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical
• Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA))

Education & Experience Requirements

• Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use
• Extensive experience in the pharmaceutical industry and a BS /BA or MS

Equal Employment Opportunity

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

How to Apply

For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.