Quality Compliance Specialist (Quality Risk Management)

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Quality Compliance Specialist (Quality Risk Management) position. This position is responsible for supporting Regeneron’s Internal Drug Product Manufacturing operations 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.

When & where:

• Location: East Greenbush, New York, United States

• Work schedule: Monday-Friday, 8am-4:30pm

Discover your role:

• 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 using appropriate methodologies (e.g., FMEA, RBIA, REM and HACCP)

• Partnering with Risk Assessment Owners to define scope, acceptance criteria, and evaluation scales

• Guiding teams through risk identification, analysis, control/mitigation, and residual risk evaluation

• Preparing and revising QRM documents

• Developing and improving the quality risk management program

• Contributing to contamination control strategy (CCS) and aseptic processing risk assessments for fill/finish operations; interface with EM, utilities, and equipment owners.

• Preparing for and supporting regulatory, customer, and internal audits/inspections

• Coaching colleagues on QRM principles and driving consistency in application

• Tracking metrics (e.g., on-time risk reviews, cycle time) and identifying opportunities for continuous improvement.

This role requires:

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, Engineering or related field, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:

  • Specialist - 2+ years

  • Senior Specialist - 5+ years

  • Level will be determined based on experience

• Excellent collaboration, influence, and communication skills

• Proficiency at facilitating cross-functional discussions

• Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required. Experience with Veeva heavily preferred.

• Having an understanding of QRM principles

• Ability to interpret complex technical and systems information and make sound risk-based decisions

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

 

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)

$67,400.00 - $128,700.00