Sr. Quality Compliance Specialist (Quality Risk Management)

We are currently looking to fill a Quality Compliance Specialist (Quality Risk Management) position. This position is responsible for supporting the work of Regeneron through the use of quality risk management (QRM). Job functions will primarily consist of the broad application of patient centered QRM across a full spectrum of processes vital to the operations. Specifically, the active facilitation of quality risk assessments, risk reviews and other quality risk-based programs supporting the Quality System (e.g., change control, deviation management, etc.). The person in this role will be consistently challenged with assignments, touching almost every phase of our process.

In this role, a typical day might include the following:

• Providing technical expertise in quality risk management to a broad base of customers throughout the organization, including Quality Assurance, Quality Control, Manufacturing, Medical Device and Facilities

• Facilitating data driven risk assessments and risk reviews

• Formulating strategies for risk controls and mitigations

• Preparing and revising QRM documents

• Developing and improving the quality risk management program

• Mentor and train staff (cross site) in quality risk management principles and practices and act as a subject matter expert and resource for QRM matters

• Manage and lead data driven risk assessments (risk identification, analysis, and ranking)

• Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System

• Advising on all QRM matters within the IOPS organization, as well as being the primary interface with customers

• Represent Regeneron’s approach to Quality Risk Management during regulatory inspections and partner audits

This role may be for you if you:

• Excel in a quality driven organization

• Have an understanding of QRM principles

• Are organized and have an attention to detail

• Can prioritize multiple assignments and changing priorities

• Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for this role you must hold a Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering or related field and the following years of experience for each level

• Sr. Quality Compliance Specialist: 5+ years

• Principal Quality Compliance Specialist: 8+ years

Relevant experience may be considered in lieu of educational requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$74,300.00 - $141,900.00