IT Compliance Analyst

Organization
Regeneron
Job Location
Tarrytown, NY
Salary
NA
Benefits

NA

Job Description

Summary:
Responsible for managing documentation (Policy, SOP, Work Instruction, and Supporting Documents)
within the IT department.

Responsibilities:
• Assisting IT QA and 18&T Management in refining and streamlining the IT documentation management processes and functions, which may include responsibility for the administration of the IT document management system and ensures the system is optimized and enhanced as needed
• Developing, managing, and ensuring efficient use of templates for all documentation types within the IT department.
• Responsible for identifying opportunities for the standardization and harmonization of documentation, as well as the prevention of document sprawl wherever possible.
• Interprets policies, standards, and regulations; and identifies potential documentation gaps or issues with eXisting documentation.
• Responsible for staying current with regulatory guidance documents and initiatives, primarily in relation to the documentation associated with the processes used within the 18&T Department.
• Develops and facilitates efficient and effective documentation development by others in accordance with Regeneron standard operating procedures and quality policies.
• Assists IT QA in ensuring that written procedures/work instructions are appropriate and in compliance with external regulations as well as internal policies and procedures; exercises judgment in evaluating compliance of documentation associated with quality systems, processes, and procedures
• Assists IT management with the implementation of a risk-based approach to documentation; prevents the development of documentation for the sake of documentation.
• Appropriately escalates any potential or perceived compliance issues
• Works with the Associate Manager of IT QA to manage documentation-related activities and follow-up on any necessary corrective and preventive actions; assists in the resolution of any conflicts.
• Drafts and issues periodic reports to IT management as requested; reports status of documents within the documentation and change control systems/processes.
• Assist with training/orientation of personnel as they engage in documentation creation/revision processes; provides guidance/training to user departments in proper and efficient use of the document management and change systems/processes.
• Assist in the development & implementation of improvements of processes and standardization of IT Department Quality systems (participate in Quality improvement initiatives)
• Ability to travel 30% of time as needed (travel may be domestic within eastern NY state).

Requirements

Experience and Required Skills:

Requirements:
• BS/BA or equivalent experience in an Information Technology or related Technical area, such as
• Computer Sciences and/or Engineering.
• 5 years of experience in the pharmaceutical industry (biotech preferred), 5-8 years of direct experience in documentation development and management activities.
• Working knowledge of IT PMO, SOLC, GAMP 5, and ITIL frameworks is highly desirable.
• Strong organizational and technical writing skills required
• Detail oriented, but focused on efficiency and workable solutions.
• Strong Project Management and organizational skills
• Strong verbal and written communication skills
• Ability to work independently with only high level guidance and supervision
• Experience in IT System design, deployment and validation/qualification is a plus
• Experience working in an FDA regulated environment with high emphasis on Validation/Qualification &
• Compliance of systems and processes is a plus
• Knowledge of 21 CFR Part 11 & Annex 11 compliance is preferred.
• Working knowledge of utilizing a risk-based approach to documentation and/or experience with Quality
• Risk Management is strongly preferred.

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