at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary. (Primary function)
The IT Systems Analyst, Tech Ops is responsible to act as a liaison between Incyte's IT team and the Quality Assurance team within the Technical Operations Business group. There will be both a project and support aspect to the role. Project related roles would be to serve as a subject matter and technical expert for the implementation of enhancements to Veeva QualitySuite Vaults (Quality Management, Document Management and Training). Support related roles would be to provide post go-live implementation and ongoing operational support for the end users and business administrators of the Veeva QualitySuite Vaults. This role will report to the IT Manager supporting Technical Operations.
Essential Functions of the Job (Key responsibilities)
Provides functional and technical support for the Veeva QualitySuite Tech Ops business administrators and users both in US and Europe.
Understands the business processes and technical workflows.
Partners with the Business system owners/Business Administrators to implement systems that support their requirements/business processes meeting delivery targets.
Serves as the subject matter and technical expert for the implementation of Projects and Enhancements to Veeva QualitySuite.
Performs/assists with configuration application testing, quality assurance, computer system validation, implementation and support.
Ability to work both independently and within a team structure and be proactive in recommending and implementing solutions.
Ensures the smooth and timely implementation of new configuration, reports and additional phase/releases to existing applications.
Addresses IT related issues beyond the core implementation team based on knowledge of related IT areas.
Prepares project related materials such as training guides, testing materials/scripts, support documents etc.
Works with the Project Manager, IT Tech Ops and QualitySuite System IT and Business Administrators to perform the above responsibilities.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Bachelor's degree or equivalent.
1-3 plus years of Pharmaceutical IT systems experience.
Veeva System Administration certification required with White Belt certification preferred.
Veeva Vault configuration and support experience with QualitySuite experience a plus.
Strong interpersonal and communication skills.
Ability to work independently and manage multiple tasks with changing priorities.
Experience with project delivery, good presentation skills, and leadership in a formal team environment.
Working knowledge of FDA compliance, computer systems validation, 21CFR Part 11 regulations and GAMP guidelines.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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