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.
In this role, 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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)