New · posted Nov 6
Regeneron · Biotechnology
Manager, QA Validation Oversight
- Rensselaer, NY
- On-site
- Full-time
- Manager
The role
Build our future together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting validation activities, ensuring global consistency, addressing recurring themes in documentation, and playing a pivotal role in regulatory inspections and compliance.
What you need
This role requires
- Bachelor’s degree in Engineering, Chemistry, or Life Sciences degree, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
- Manager: 7+ years
- Senior Manager: 8+ years
- Level will be determined based on experience
- Hands-on validation experience in a GMP-regulated environment
- Enjoying building strong, collaborative relationships across global internal teams
- A continuous improvement mindset
- Leadership skills that inspires and guides a multi-tiered team
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'll do
Discover your role
- Ensuring alignment between validation activities and production initiatives to support successful transition of processes from development to manufacturing.
- Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.
- Reviewing and approving validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.
- Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans.
- Conduct one-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.
Pay and benefits
$110,100 – $179,500 a year
Employer provided$110,100.00 - $179,500.00
Annual bonuses or incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Rensselaer, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Rensselaer, NYWorking 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 · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Manager roles in the US10 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $110,100 | — | $179,500 |
| All US (middle half) | $134,250 | $139,500 | $156,250 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 97 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 15 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification6
- Documentation and SOPs4
- Collaboration and leadership4
- GMP and compliance2
- Quality systems and risk2
- Clinical trial conduct2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Validation & CQV work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and PracticesNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
Company hiring pulse
Regeneron on Regulatory Jobs
- 177
- Open roles
- 177
- Distinct roles
- 11
- Locations
By discipline
- Quality75 42%
- Clinical74 42%
- Regulatory29 16%
By level
- Associate & Specialist58 33%
- Manager53 30%
- Director52 29%
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Manager, QA Validation Oversight at Regeneron
Open until filled. $110K–$180K a year, employer provided.