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Change Control Coordinator- QS Specialist III

米国 - カリフォルニア - フォスターシティ品質保証正社員

仕事内容

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:

  • 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..
  • 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. m
  • Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS expectations.
  • 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.
  • 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 & Skills:

  • Will need to demonstrate the ability to manage multiple change controls of varying complexity and scope of tasks in a fast-paced environment to meet timelines.
  • 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.
  • Demonstrates Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively.
  • Demonstrate strong scientific/technical understanding of small and/or large biologic molecule operations and related regulations/guidelines.
  • Demonstrates knowledge of Six Sigma andLEAN concepts, and risk management tools for assessing change impact.
  • Demonstrate knowledge and application of risk management principles, including identification, controls, mitigations, and actions.
  • Demonstrates excellent verbal and written communication skills to all levels of the organization. Technical writing skills required.
  • Demonstrate ability to problem solve and lead process improvements.
  • Demonstrate ability to lead cross-functional meetings and make decisions as QA representative.
  • Demonstrates strong interpersonal skills with ability to influence, negotiate, manage conflict, and negotiate.
  • Demonstrates proficiency in Microsoft Office applications.

Education and Experience:

  • 5+ years of relevant experience in a GMP environment for biologics manufacturing and a BS or BA, with change control experience a must. (OR)
  • 3+ 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.

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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 jobs in France:

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