Quality Compliance Specialist (Change Controls)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.  Regeneron is currently looking for a Quality Compliance Specialist to join our Quality Assurance team. This position will focus on internal change controls. The Quality Compliance Specialist ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to change control activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Rensselaer, New York, United States
• Work model: Monday-Friday, 8am-4:30pm

What you'll do:

• Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements
• Facilitate cross-functional meetings, offering guidance and consultation to change control owners throughout the process
• Build strong relationships with end users, serving as a go-to resource on standard change control processes
• Partner with quality assurance colleagues and system end users to identify, develop, and implement continuous improvements to the change control system, processes, and related procedures
• Interpret compliance and regulatory requirements, translating them into departmental systems, procedures, and documentation
• Support regulatory and customer audits as a subject matter expert on change control
• Apply strong working knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory standards
• Analyze and interpret process and systems information, technical procedures, reports, and regulations to support sound decision-making in a cGMP environment
• Leverage strong digital proficiency in MS Word, Excel, and PowerPoint; experience with Veeva/QMS is a plus

Let’s find out if we’re a fit:

• Requires B.S in life sciences or related field; may substitute proven experience for education requirement
  • Associate Quality Compliance Specialist: 0-2+ years of experience
  • Quality Compliance Specialist: 2+ years of experience
  • Level will be determined based on experience

Thrive today. Grow tomorrow.

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)

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)

$62,355.00 - $110,000.00