Quality Systems Specialist - Document Management Systems

The QS Specialist provides oversight to aspects of the Quality Management System (QMS). Namely this position will entail oversight of IOPS Regeneron's Document Management System. This position coordinates across all IOPS functions that interact with the Document Management System with the aim to collect feedback and implement updates in support of continuous improvement, quality, and compliance.

A typical day in this role may include:

• Support daily system focused operational activities such as monitoring of key performance indicators across applicable systems and processes.
• May prepare metrics for reports to management.
• Develops and coordinates the creation of tools, resources, and programs to provide document management processes.
• Provides guidance to team members on the proper use of document and record management systems.
• Assist senior QS employees in support of maintaining, monitoring, and improving quality system elements including:
  • Conducting assessments or evaluations on the effectiveness of processes.
  • Monitoring performance over time (routine monitoring and post-implementation monitoring).
• Balances both daily and project-based work, including leading projects.
• Assists as needed in audits, inspections or investigations into processes.
• Assists in the revision of procedures.

This role may be for you if you:

• Demonstrate knowledge of Document Management standards and regulations, including systems such as Veeva or MYQUMAS.
• Ability to take instruction, work in a team and in an individual capacity.
• Excellent organizational and communication skills to support interfacing with users across a range of managerial or proficiency levels.
• Exhibits results driven behavior; is comfortable in dealing with ambiguity, and is comfortable learning on the fly.
• Excellent time and project management skills with the ability to manage diverse tasks simultaneously.
• Strong attention to detail.
• Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Working knowledge of Microsoft Project and SharePoint is a plus.

In order to be considered for this position, you must hold a BA/BS degree and

• Specialist: 2 years of industry/relevant experience
• Senior Specialist: 5 years of industry/relevant experience.
• Previous QA System oversight experience, including Document Management Systems such as Veeva or MYQUMAS highly preferred.
• May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.

Salary Range (annually)

$66,400.00 - $126,800.00