IT Compliance Analyst

Location
Troy, New York
Posted
Oct 12, 2021
Ref
REGEA0026R3573
Required Education
Bachelors Degree
Position Type
Full time

We are currently looking to fill an IT Compliance Analyst.  Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our IT Compliance Analysts ensure that the IT group is operating in compliance with regulatory requirements and Regeneron internal procedures and act as the key liaison between the IT and Quality Assurance groups.
    
As an IT Compliance Analyst, a typical day might include the following:

  • Ensuring personnel are operating in compliance with regulations and procedures

  • Assisting personnel in participating in and successfully navigating through the Quality Management Processes

  • Providing technical writing assistance

  • Assisting personnel in writing/responding to deviations/events including detailed event investigation and root cause analysis 

  • Representing IT at Deviation/Event meetings 

  • Tracking and facilitating the remediation activities associated with IT-related CAPAs

  • Managing or assisting SMEs with IT Change Controls 

  • Evaluating, developing and modifying Policies and Standard Operating Procedures to meet regulatory requirements and obligations 

  • Facilitate the document management tasks associated with GxP Electronic Document Management System

  • Ensuring procedures are in compliance with regulatory and corporate requirements

  • Representing IT or assisting Subject Matter Experts (SMEs) during internal and external audits

  • Assisting personnel in interactions with Quality Assurance personnel and the Quality Management System

  • Tracking and reporting on Quality metrics

  • Working closely with QA Validation to ensure systems are validated and maintained in a validated state

  • Ensuring IT operational controls are in place and maintained throughout the system lifecycle (e.g. periodic reviews, disaster recovery testing, performance monitoring etc.)

  • Tracking and verifying that all IT Administration activities are completed as per procedures

  • Championing Data Integrity for all IT systems

  • Completing GAP assessments and remediation efforts

This role might be for you if you have:

  • Knowledge of cGMP, 21 CFR Part 11, Annex 11, GAMP 5

  • Knowledge of and experience with Quality Management Systems

  • Knowledge of and experience with SDLC methodologies in a cGMP regulated environment (preferred)

To be considered for the IT Compliance Analyst you must have a BS/BA in a related field and the following minimum amounts of pharmaceutical/biotechnology industry experience for each level:

  • Associate Analyst: 0-2 years

  • Analyst: 2+ years

  • Sr Analyst: 5+ years

An equivalent combination of education and experience considered. Level is determined based on qualifications relevant to the role.



Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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