Getting Hired
Overview
At Gilead, we’re creating a healthier world and tackling diseases such as HIV, viral hepatitis, COVID-19 and cancer. We pursue therapies that help improve lives and improve access to these therapies globally. We strive for collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in discovery and development of life-changing scientific innovations. We believe every employee deserves a great leader. People Leaders are the cornerstone of the employee experience at Gilead and Kite. As a people leader now or in the future, you are a 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 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, etc.)
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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
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. 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 the compensation, benefits and wellbeing page. Notes on Benefits and Equal Employment Opportunity: Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Gilead is committed to equal employment opportunity and fostering an inclusive work environment. Applicants will be evaluated without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants with disabilities upon request. 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 supports diversity of thought and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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At Gilead, we’re creating a healthier world and tackling diseases such as HIV, viral hepatitis, COVID-19 and cancer. We pursue therapies that help improve lives and improve access to these therapies globally. We strive for collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in discovery and development of life-changing scientific innovations. We believe every employee deserves a great leader. People Leaders are the cornerstone of the employee experience at Gilead and Kite. As a people leader now or in the future, you are a 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 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, etc.)
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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
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. 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 the compensation, benefits and wellbeing page. Notes on Benefits and Equal Employment Opportunity: Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Gilead is committed to equal employment opportunity and fostering an inclusive work environment. Applicants will be evaluated without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants with disabilities upon request. 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 supports diversity of thought and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
#J-18808-Ljbffr