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New · posted Oct 20

Regeneron · Biotechnology

Quality Compliance Specialist

  • Rensselaer, NY
  • On-site
  • Full-time
  • Associate & Specialist
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EmploymentFull-time
Deadline

Open until filled

The role

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.

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)

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.

What you need

What you'll do

  1. Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements
  2. Facilitate cross-functional meetings, offering guidance and consultation to change control owners throughout the process
  3. Build strong relationships with end users, serving as a go-to resource on standard change control processes
  4. 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
  5. Interpret compliance and regulatory requirements, translating them into departmental systems, procedures, and documentation
  6. Support regulatory and customer audits as a subject matter expert on change control
  7. Apply strong working knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory standards
  8. Analyze and interpret process and systems information, technical procedures, reports, and regulations to support sound decision-making in a cGMP environment
  9. Leverage strong digital proficiency in MS Word, Excel, and PowerPoint; experience with Veeva/QMS is a plus

Pay and benefits

$67,400 – $110,000 a year

Employer provided
How this compares

$67,400.00 - $110,000.00

  • Student loan paydown program

  • Tuition reimbursement

  • Family care benefits

  • Relocation assistance

  • Inclusion, culture and well-being programs

  • 401(k) company match

Where you'll work

Rensselaer, NYOn-siteOpen in Maps (opens in a new tab)

More jobs in Rensselaer, NY

Working conditions

When & where

  • Location: Rensselaer, New York, United States
  • Work model: Monday-Friday, 8am-4:30pm
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word

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.

Job intelligence

The context around this role

Live data · October 20, 2026

Salary intelligence

How the pay compares

This role's midpoint is 10% above the US median for Quality Assurance roles at this level.

This roleEmployer provided

$67,400 to $110,000 a year

Associate & Specialist roles in New York19 roles publishing pay

Middle half $61,250 to $88,500, median $86,000

Associate & Specialist roles in the US172 roles publishing pay

Middle half $59,000 to $93,625, median $80,500
Annual base pay
Annual base payLowMedianHigh
This role$67,400—$110,000
New York$61,250$86,000$88,500
All US$59,000$80,500$93,625

This role: Regeneron's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 895 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.

  1. This role

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $81K median243 open
  2. Next step

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $120K median381 open
  3. Later

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $155K median138 open
  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median118 open
  5. Later

    VP & Executive

    Often: AVP · Executive Director Quality, Cell & Gene Therapy

    $302K median15 open

Skills DNA

What this role leans on

How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 7 linesDocumentation and SOPs: 4 linesQuality systems and risk: 8 linesData and digital systems: 1 lineCollaboration and leadership: 2 linesGMPDocumentationQuality systemsData systemsTeamwork
  • Quality systems and risk8
  • GMP and compliance7
  • Documentation and SOPs4
  • Collaboration and leadership2
  • Data and digital systems1

Company hiring pulse

Regeneron on Regulatory Jobs

73
Open roles
63
Distinct roles
9
Locations

By discipline

  • Quality51 70%
  • Regulatory19 26%
  • Compliance & Safety3 4%

By level

  • Associate & Specialist36 49%
  • Manager21 29%
  • Senior & Principal9 12%
See all 73 Regeneron roles

More roles at Regeneron

All 73 Regeneron roles

Similar Quality Assurance roles elsewhere

Quality Compliance Specialist at Regeneron

Open until filled. $67K–$110K a year, employer provided.

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