Job Information
Gilead Sciences, Inc. Manager, Quality Systems in Foster City, California
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) 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
Manager, Quality Systems
Responsibilities:
Supports, facilitates, and adapts the Gilead Quality Management System for equipment/utilities/computer systems to ensure that it meets regulatory and industry standards and expectations.
Work closely with the Business Process Owners, Facilities, and Engineering/IT teams to ensure that the deployment of GxP systems meets company standards and relevant regulations and that systems are maintained in a validated state.
Reviews and approves validation deliverables for medium-to-large-sized projects.
Review and approve procedures, work instructions, and other governing documents to support Gilead’s GxP systems.
Provide oversight and QA approvals for GxP Deviations, CAPAs, and change controls to ensure activities are conducted in compliance with Gilead procedures and regulatory requirements.
Provide expert guidance on equipment, utilities, and computer systems topics.
Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs).
Interface with regulatory agencies as required.
Performs various activities to ensure compliance with quality systems, quality procedures, and applicable regulatory requirements.
Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
Participate in developing training programs regarding all aspects of quality systems administration.
Participates in compliance audits as required.
Knowledge and Skills:
Demonstrates proficiency in regulatory requirements pertaining to equipment/utilities/computer systems validation/qualification in GxP environments.
Demonstrates proficiency in understanding and applying GMP regulations related to manufacturing, test laboratories, and facility operations.
Demonstrates proficiency in applying QA systems principles, concepts, industry practices, and standards.
Demonstrate a strong technical and analytical understanding of Biologics Manufacturing.
Demonstrate knowledge and application of risk management principles, including identification, controls, mitigations, and actions.
Demonstrate ability to problem solve and lead process improvements.
Demonstrate ability to lead cross-functional meetings and make decisions as a QA representative.
Demonstrates strong verbal, technical writing, and interpersonal skills.
Experience interfacing with regulatory authorities to present company methodologies and deliverables during inspections.
Minimum Qualifications:
- Bachelors degree and 6+ years of relevant experience in a GMP environment-related field; or a Masters degree and 4+ years of relevant experience in a GMP environment related field.
The salary range for this position is: $133,280.00 - $172,480.00. 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' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.