Document Control Lead
Document Control Lead
United States - North Carolina - Raleigh
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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 Lead 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 managing 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 efficient and compliant creation of GxP computer system documentation and procedures by staff in Gilead's electronic document management system (EDMS) by developing and providing document templates, instructions and training. Author or revise standard operating procedures related to document control as needed.
- Monitor execution of document control workflows within the EDMS and provide support to facilitate compliance with applicable procedures. Support compilation of department metrics and report out to management.
- Manage the execution of EDMS workflows for the creation, revision, obsoletion and periodic review of procedures. Ensure procedures meet template requirements and adhere to review and approval requirements. Ensure that all impacts to related documents are identified and addressed.
- Ensure that GxP paper records produced by staff are retrieved and archived in controlled storage per GxP record retention requirements. Ensure that electronic copies of GxP paper records are produced in compliance with True Copy requirements. Facilitate understanding and application of Good Documentation Practices in accordance with ALCOAA principles.
- Lead the continuous improvement of document control processes and systems, including the replacement of legacy paper forms with electronic forms, electronic signatures and workflow. Contribute to company-wide document control improvement initiatives.
- Collaborate with project and system managers to identify and meet demand for document control services.
- Support quality investigations, regulatory audits and inspections as required
- High School and Nine Years Experience OR Associates Degree and Seven Years Experience OR Bachelor's Degree and Five Years' Experience OR Masters' Degree and Three Years' Experience
- 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.
- Direct experience with the creation and continuous improvement of document control procedures, templates, forms and delivery of user training.
- Demonstrates effective organizational, planning and time management skills. Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities.
- 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
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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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' 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 Current Gilead Employees and Contractors:
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