Gilead Sciences
Sr Specialist, Quality Systems
Gilead Sciences, San Francisco, California, United States, 94199
Overview
Join to apply for the
Sr Specialist, Quality Systems
role at
Gilead Sciences . 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. Join Gilead and help create possible, together.
Job Responsibilities
Independently and proactively initiate and drive the planning, execution, and completion of change management projects
Develop and implement strategies to mitigate risks within the change management process and change control system
Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations
Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals
Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training effectiveness
Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations
Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly
Supports management and monitoring of change records 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
Work closely with Change Management Business Process Lead and business support team members to support enhancements of the change control QMS processes and business process
Supports the maintenance and improvement of quality systems processes, as needed
Works directly with operating entities and internal clients to ensure follow-up of change tasks
Participate in compliance audits as required
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
Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards, particularly related to change management
Demonstrates ability to effectively manage multiple complex projects and priorities simultaneously
Demonstrates ability to work independently
Has 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
Experience in Quality Management System (e.g. Veeva, TrackWise, MasterControl)
Demonstrates strong proficiency in Microsoft Office applications
Basic Qualifications
BS or BA + 7+ years of relevant experience in a GMP environment related field
OR
MS + 5+ years of relevant experience in a GMP environment related field
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account
Compensation and Benefits The salary range for this position is: $136,340.00 - $176,440.00. 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
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. Reasonable accommodation requests may be directed to ApplicantAccommodations@gilead.com.
For Current Gilead Employees And Contractors please apply via the Internal Career Opportunities portal in Workday.
Seniority level: Not Applicable | Employment type: Full-time | Job function: Quality Assurance | Industries: Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Gilead Sciences. Get notified about new Quality System Specialist jobs in San Francisco Bay Area.
#J-18808-Ljbffr
Join to apply for the
Sr Specialist, Quality Systems
role at
Gilead Sciences . 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. Join Gilead and help create possible, together.
Job Responsibilities
Independently and proactively initiate and drive the planning, execution, and completion of change management projects
Develop and implement strategies to mitigate risks within the change management process and change control system
Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations
Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals
Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training effectiveness
Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations
Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly
Supports management and monitoring of change records 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
Work closely with Change Management Business Process Lead and business support team members to support enhancements of the change control QMS processes and business process
Supports the maintenance and improvement of quality systems processes, as needed
Works directly with operating entities and internal clients to ensure follow-up of change tasks
Participate in compliance audits as required
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
Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards, particularly related to change management
Demonstrates ability to effectively manage multiple complex projects and priorities simultaneously
Demonstrates ability to work independently
Has 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
Experience in Quality Management System (e.g. Veeva, TrackWise, MasterControl)
Demonstrates strong proficiency in Microsoft Office applications
Basic Qualifications
BS or BA + 7+ years of relevant experience in a GMP environment related field
OR
MS + 5+ years of relevant experience in a GMP environment related field
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account
Compensation and Benefits The salary range for this position is: $136,340.00 - $176,440.00. 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
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. Reasonable accommodation requests may be directed to ApplicantAccommodations@gilead.com.
For Current Gilead Employees And Contractors please apply via the Internal Career Opportunities portal in Workday.
Seniority level: Not Applicable | Employment type: Full-time | Job function: Quality Assurance | Industries: Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Gilead Sciences. Get notified about new Quality System Specialist jobs in San Francisco Bay Area.
#J-18808-Ljbffr