---
title: 'Lead Specialist, QA Validation at ElevateBio'
canonical: 'https://feeny.ai/job/lead-specialist-qa-validation-elevatebio-waltham-hnsk1tcfycb8'
type: 'job'
last_seen: '2026-10-16'
---

# Lead Specialist, QA Validation at ElevateBio

- **Company:** ElevateBio
- **Location:** Waltham, MA
- **Posted:** 2026-10-01
- **Last confirmed live:** 2026-10-16
- **Apply:** https://elevate.bio/about/jobs/6213028004?gh_jid=6213028004

## Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role:

ElevateBio is looking for a Lead QAV Specialist to provide QA oversight for the BaseCamp Waltham Commissioning, Qualification, and Validation activities. In this role the Lead will be responsible for managing cGMP compliance from a Quality Assurance prospective of validation master plans, project validation plans, facility commissioning/qualification, utility commissioning/qualification, process equipment qualification, and lab equipment and instrument qualification. In addition, this position will support all risk assessments, technical reports, change controls, deviations and CAPAs related to commissioning, qualification, and validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.

Here’s What You’ll Do:

- Leads QA partnership for operational activities for Engineering groups (i.e. commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories). Recognized as quality expert for these programs and acts as direct escalation pathway for teams.
- Leads QA oversight of quality events for ongoing validation and engineering operations (equipment upgrades, deviations, and related CAPAs). Scope inclusive of manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
- Independently evaluates CQV change controls by authoring impact assessments and provides QA support and approval for associated CQV activities.
- Leads QA oversight for CMMS, collaborates with Engineering and Lab and Site Services to evaluate Quality impact for database modification requests.
- Liaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.
- Potential to provide administration support for Kneat electronic validation system.
- Leads QA oversight and support for periodic review and requalification activities.
- Manage team of QAV personnel including both FTE and contractor resources
- QA SME for Equipment Relocation program, supports all relocation activities that arise due to ongoing manufacturing needs.

Requirements:

- Bachelor’s degree and at least 5 years of related experience; or Master’s degree with at least 3 years of related experience; or a PhD with up to 1 year of related experience.
- Strong knowledge of 21 CFR, ICH, EU regulations
- Prior experience in Cell and Gene Therapy manufacturing a plus.
- Prior management experience a plus.
- Experience in new facility commissioning and qualification preferred.
- Experience with Blue Mountain CMMS system desired.
- Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint, Kneat, Veeva, Blue Mountain CMMS)
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
- A team player, who listens effectively and invites response and discussion.
- A collaborator who communicates in an open, clear, complete, timely and consistent manner.

Physical and Environment Requirements:

- Ability to stand, walk, bend and stretch for extended period of time
- Ability to lift 15-20 lbs
- Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
- Ability to perform routine repetitive motions with use of arms, wrists and hands

The budgeted range for this position is $105,000 - $145,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

## About ElevateBio

## Company Overview
- **One-liner**: ElevateBio is a technology-driven contract development and manufacturing organization (CDMO) that powers the creation of genetic medicines by providing integrated gene editing, process development, and cGMP manufacturing capabilities.
- **Entity Type**: Private (Series D – raised $401M in November 2025; total capital raised ~$1.3B)
- **Headquarters**: Waltham, Massachusetts, United States
- **Founded**: 2017
- **Founders**: Not publicly available

## Core Business
- Primary industry: Biopharmaceutical CDMO (cell and gene therapy, gene editing, mRNA therapeutics)
- Target customers: Biopharmaceutical innovators (B2B, enterprise)
- Mission: “To be the world’s most indispensable advanced therapy technology company, changing how companies operate, how products are created, and how disease is treated.”

## Products & Services
- **Gene Editing Tools & Discovery Services**: One of the world’s largest toolboxes of gene editing technologies (e.g., CRISPR enzymes), enabling flexible editing and broad access to the genome. Includes discovery services to move from target to optimized therapeutic candidate.
- **Process Development**: Scalable, robust manufacturing process design from preclinical through commercial scale.
- **Manufacturing (cGMP)**: Viral vectors, cell therapies, mRNA therapeutics, and lipid nanoparticles (LNP). Multi-modality capabilities with 98% batch success rate. Automated cell therapy manufacturing platform.
- **Regulatory Support & Commercialization**: Navigate CMC regulatory strategy from IND through BLA.
- **Next-Generation Sequencing / Rapid Analytics**: In-house analytics for quality and characterization.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private company)
- **Key Metric**: Total funding ~$1.3 billion (as of Series D close in November 2025)
- **Notable Investors/Partners**: Novo Nordisk (multi-target R&D collaboration worth up to ~$1.9B), Amazon Web Services (generative AI for CRISPR discovery), Sartorius (automated cell therapy platform), University of Pittsburgh / Richard King Mellon Foundation ($100M grant for biomanufacturing facility)
- **Growth Signals**: CNBC Disruptor 50 in 2021, 2023, 2024, 2025; Fast Company’s 2024 Most Innovative Companies; Boston Globe Top Place to Work (2022, 2023); first genetic medicines manufacturer to achieve ICMC multi-modality certification; opened flagship purpose-built biomanufacturing facility in Waltham, MA; achieved 98% manufacturing batch success rate across cell therapy, viral vector, and mRNA batches.

## Competitive Advantages
- **Integrated Model**: Science, process development, manufacturing, and quality operate under one roof – no hand-offs between stages.
- **Continuous Technology Investment**: Automation, AI-assisted design, and process innovation embedded as a permanent operating principle to reduce costs and timelines.
- **Multi-Modality Expertise**: Covers viral vectors, cell therapies, mRNA, LNP delivery, and gene editing – enabling partners to switch modalities without restarting.
- **Proprietary Gene Editing Toolbox**: Acquired Life Edit Therapeutics, adding one of the largest collections of gene editing enzymes and patents.
- **Industry-Leading Quality**: ICMC certification across multiple modalities and 98% batch success rate exceed industry standards.

## Strategic Focus
- Expand gene editing capabilities and delivery technologies (e.g., LNP in vivo delivery for nuclease editing).
- Scale manufacturing capacity through new facilities (Waltham flagship, Pittsburgh site).
- Deepen collaborations with pharma (Novo Nordisk) and tech (AWS) to accelerate therapy development.
- Apply generative AI to broaden CRISPR discovery for complex monogenic and polygenic diseases.
- Establish manufacturing blueprints for novel modalities such as base-edited therapies.

## Why Work Here
- **Culture**: Described as a group of “explorers” passionate about constant discovery, new technology, and progress in life-transforming therapies.
- **Benefits**: Medical, vision, and dental covered at 90%; low deductible; employer-paid life insurance and disability; 401(k) with 4% match (no vesting); 12 weeks parental leave; competitive PTO; commuter reimbursement; monthly cell phone stipend; fitness reimbursement; access to wellness apps.
- **Development**: LinkedIn Learning access, Insights Discovery training, ongoing professional development and manager training.
- **Work Environment**: Roles primarily based in Waltham, MA (on-site for manufacturing and lab positions). Hybrid/remote not explicitly stated but likely limited for operational roles.
- **Recognition**: Boston Globe Top Place to Work; named to CNBC Disruptor 50 multiple years.

## Sources
1. [elevate.bio](https://elevate.bio/)
2. [elevate.bio/about](https://elevate.bio/about/)
3. [elevate.bio/about/careers](https://elevate.bio/about/careers/)
4. [elevate.bio/about/our-journey](https://elevate.bio/about/our-journey/)
5. [LinkedIn](https://www.linkedin.com/company/elevatebio)

## Other roles at ElevateBio

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- [Associate Director, Commercial Operations](https://feeny.ai/job/associate-director-commercial-operations-elevatebio-waltham-r8n0qy392tf2) — Waltham, MA
- [Validation Engineer I](https://feeny.ai/job/validation-engineer-i-elevatebio-waltham-f3fg51tn31g7) — Waltham, MA
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