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Quality Systems Specialist III

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Feb 15, 2024

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

Quality Systems Specialist III
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.
Job Description



Job Responsibilities:
  • Independently conduct, complete, and thoroughly document critical, major, and minor deviation investigations related to GxP operations, with a focus on investigations associated with biologics/large molecule manufacturing processes, facilities, or systems. Will need to demonstrate the ability to manage multiple deviations in a fast-paced environment and meet tight timelines.
  • 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 and technical understanding of large molecule drug development and manufacturing 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 monitoring 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.
  • Supports management review process through development and generation of quality system metrics and trending, and escalates issues as required.
  • Supports the maintenance and improvement of 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 and a forensic mindset 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 technical 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:
  • 6+ years of relevant experience in a GMP environment related field and a BS or BA, with 2+ years of experience in biologics/large molecule clinical/commercial operations setting.
  • 4+ years of relevant experience and a MS.


The salary range for this position is: $115,260.00 - $149,160.00. 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.

For jobs in the United States:


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.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:


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






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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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