Principal QA Specialist - IT

Overview

Working within the Quality Assurance organization this position is responsible for ensuring IT systems, programs, and quality events are robust and compliant. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal company policies and procedures.

Typical day responsibilities As a Principal QA Specialist, a typical day might include the following:

• Supporting IT related change controls, CAPAs, data integrity initiatives, deviations, internal and external audits, and other verticals to ensure a robust, compliant state of programs
• Engaging with Corporate and IOPS IT to ensure IT processes and procedures meet Regeneron's Quality System requirements
• Reviewing, editing, and approving SOPs, deviation notifications, deviation investigations, and corrective actions
• Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions
• Collaborating, investigating, and troubleshooting to determine solutions or recommendations for changes and/or improvements
• Participating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives
• Supporting the development, review, and approval of Quality Assurance Agreements (QAA) along with the Approved Supplier List (ASL) process
• Contributing information reflecting best practices, industry trends, and recommendations for strategic plans to drive changes and improvements
• Communicating project and program status and metrics to Senior Management

Who might be a good fit?

• Demonstrate strong interpersonal skills and can collaborate effectively
• Can balance changing priorities with a growing workload by communicating timely decisions
• Demonstrate knowledge of 21CFR11 and Annex 11 as well as MHRA, FDA, and WHO data integrity guidelines
• Have an understanding of the interdependencies of change management, deviation, and continuous improvement
• Can work in a dynamic organization where innovative solutions are required to ensure a high level of quality is achieved with aggressive timelines

To be considered for this position you should have a BSc/BA/BEng in IT/Automation/Analytics or related field and 5 7 years of experience or an equivalent combination of education and experience. Recent experience in a data integrity role is preferred; however, it is not required.

Benefits

We have an inclusive culture that provides comprehensive benefits. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For other countries' specific benefits, please speak to your recruiter.

Equal Opportunity Statement

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.