Principle QA Specialist - IT

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.

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 ensuring 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 drives changes and improvements

• Communicating project and program status and metrics to Senior Management

This role might be for you if you:

• 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 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 equivalent combination of education and experience. Recent experience in a data integrity role is preferred; however, it is not required. 

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  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 additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.