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.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
€63,200.00 - €103,200.00