Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Job Description
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 pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.
The Gilead Business Services center in Raleigh's Research Triangle region will be home to some of the company's critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead's business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization. Please check out more at https://nccareers.gilead.com/
The Document Control Specialist will have expertise and experience in document control and records management, has a general knowledge of biopharmaceutical manufacturing and a good understanding of GxP regulations. This role is a subject matter expert in document control including the creation, revision, and retirement of standard operating procedures and computer system documentation. Primary responsibilities include the execution of documentation workflows to meet departmental needs; onsite and offsite archival and tracking of records; retrieval of records to support audits, inspections and investigations. This role will interface closely with other cross-functional groups.
Job Duties and Responsibilities:
Basic Qualifications:
Preferred Qualifications:
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 careers@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Job Description
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 pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.
The Gilead Business Services center in Raleigh's Research Triangle region will be home to some of the company's critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead's business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization. Please check out more at https://nccareers.gilead.com/
The Document Control Specialist will have expertise and experience in document control and records management, has a general knowledge of biopharmaceutical manufacturing and a good understanding of GxP regulations. This role is a subject matter expert in document control including the creation, revision, and retirement of standard operating procedures and computer system documentation. Primary responsibilities include the execution of documentation workflows to meet departmental needs; onsite and offsite archival and tracking of records; retrieval of records to support audits, inspections and investigations. This role will interface closely with other cross-functional groups.
Job Duties and Responsibilities:
- Support the efficient and compliant creation of GxP computer system documentation in Gilead's electronic document management system (EDMS).
- Participate in the execution of EDMS workflows for the creation, revision, obsoletion and periodic review of procedures. Ensure that procedures meet template requirements and adhere to review and approval requirements. Ensure that all impacts to related documents are identified and addressed.
- Archive and maintain GxP paper records in controlled storage per GxP record retention requirements. As needed, produce electronic copies of GxP paper records in compliance with True Copy requirements. Facilitate understanding and application of Good Documentation Practices in accordance with ALCOAA principles.
- Author or revise standard operating procedures related to document control as needed. Produce document control metrics and report out to management.
- Facilitate continuous improvement of department specific document control processes and systems, including the replacement of legacy paper forms with electronic forms. Contribute to company-wide document control improvement initiatives.
- Collaborate with department managers to establish document control priorities and deadlines.
- Support quality investigations, regulatory audits and inspections as required.
Basic Qualifications:
- High School and Six Years Experience OR Associates Degree and Five Years Experience OR Bachelor's Degree and Four Years' Experience
Preferred Qualifications:
- Demonstrates strong working knowledge of Electronic Document Management Systems (EDMS).
- Has direct experience with the implementation and use of an EDMS.
- Hands on experience with the provision of high-volume document control services in a GxP regulated environment.
- Strong understanding of the current pharmaceutical industry and applicable regulations, highly desired.
- Demonstrates in-depth understanding of system administration and problem resolution.
- Demonstrates effective organizational, planning and time management skills.
- Excellent communication, analytical, and organizational skills, using modern technology platforms. Strong verbal, technical writing and interpersonal skills.
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
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 careers@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' 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.
Gilead Sciences, Inc. is a research-based biopharmaceutical 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, hematology and oncology, inflammatory and respiratory diseases and cardiovascular conditions.