Quality Systems Specialist III

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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
 

Job Responsibilities

• Independently conduct, complete, and thoroughly document critical, major, and minor deviation investigations, including investigations related to biologics manufacturing processes, facilities, or systems and other GxP operations.  Will need to demonstrate ability to manage multiple deviations and meet original due dates.
• Facilitate cross-functional meetings with internal and external parties to ensure alignment with Root Cause, Impact Assessments, and CAPA development. 
• Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
• Identifying issues during the investigation that would require escalation to management, and alerting management in a timely manner. 
• Supports management and tracking of quality system records (i.e. Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental metric targets and maintenance of associated tracking tools/databases.   
• Responsible for sending periodic reminder notifications to leads/coordinators. 
• Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required. 
• Supports the maintenance and improvement to quality systems processes, as needed 
• Works directly with operating entities and internal clients to ensure follow-up of quality issues. 
• Participate in the development of training programs regarding all aspects of producing quality products, as required. 
• Participate in compliance audits as required. 
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. 
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
• Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
• Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks

Knowledge & Skills

• Demonstrates proficiency in Good Manufacturing Practices (GMPs)
• Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.
• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
• Demonstrate strong scientific/technical understanding of biologics/large molecule operation and related regulations/guidelines.
• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.
• Demonstrate knowledge and application of risk management principles, including identification, controls, mitigations, and actions.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrate ability to problem solve and lead process improvements.
• Demonstrate ability to lead cross-functional meetings and make decisions as QA representative.
• Demonstrates strong verbal, technical writing, and interpersonal skills.
• Demonstrates proficiency in Microsoft Office applications.

Education and Experience

• At least 6 years of relevant experience in a GMP environment related field and a BS or BA.
• At least 4 years of relevant experience and a MS.
• Prior experience in biologics pharmaceutical industry is preferred.

The salary range for this position is: $117,895.00 - $152,570.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
 

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.