Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Summary: The IOPS (Industrial Operations and Product Supply) IT Compliance Analyst is responsible for ensuring that the IOPS IT group is operating in compliance with regulatory requirements and Regeneron internal procedures as well being the key liaison between the IOPS IT and Quality Assurance groups.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Ensures IOPS IT procedures are in compliance with regulatory and corporate requirements.
* Ensures IOPS IT personnel are operating in compliance with regulations and procedures.
* Assists IOPS IT personnel in interactions with Quality Assurance personnel and the Quality Management System.
* Evaluates, develops and modifies IOPS IT Policies and Standard Operating Procedures to meet regulatory requirements and obligations.
* Provides IOPS IT with technical writing assistance.
* Tracks and reports on IOPS IT Quality metrics.
* Works closely with QA Validation to ensure IOPS IT systems are validated and maintained in a validated state.
* Represents IOPS IT or assists IOPS IT Subject Matter Experts (SMEs) during internal and external audits.
* Ensures IT operational controls are in place and maintained throughout the system lifecycle (e.g. periodic reviews, disaster recovery testing, performance monitoring etc.).
* Tracks and verifies that all IT Administration activities are completed as per procedures.
* Champions Data Integrity for all IT systems.
* Represents IOPS IT at NOE/Deviation/Event meetings.
* Assists IOPS IT personnel in writing/responding to deviations/events including detailed event investigation and root cause analysis.
* Tracks and facilitates the remediation activities associated with IT-related CAPAs.
* Assists IOPS IT personnel in participating in and successfully navigating through the Quality Management Processes.
* Manages or assists IOPS IT SMEs with IOPS IT Change Controls.
* Ensures IOPS IT training is adequate and current.
* Completes GAP assessments and remediation efforts.
Knowledge and Skills:
* 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.
* Working knowledge of utilizing a risk-based approach to documentation and/or experience with Quality Risk Management is strongly preferred.
* Excellent technical writing ability and communication skills.
* Excellent attention to detail, computer skills, and ability to adapt to new systems/technologies.
* Ability to work independently with high level guidance and supervision.
Education and Experience:
* BS/BA in related field required; may substitute relevant industry experience for educational requirement
* Associate IT Compliance Analyst: Minimum of 1 year of relevant experience in the pharmaceutical or biotechnology industry required
* IT Compliance Analyst: Minimum of 3 years of relevant experience in the pharmaceutical or biotechnology industry required
* Senior IT Compliance Analyst: Minimum of 5 years of relevant experience in the pharmaceutical or biotechnology industry required
* QA experience within an IT department strongly preferred
* Title level (Associate Analyst, Analyst, or Senior Analyst) will be determined based on skills and experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.