CRISPR Therapeutics · 1 week ago
Senior Manager, Quality Management Systems
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$130K/yr - $150K/yr
10+ years expCRISPR Therapeutics is a pioneering company in gene editing with a diverse portfolio of product candidates. The Senior Manager, Quality Management Systems will be responsible for managing and administering the Quality Management System, focusing on deviation, change control, and CAPA processes to ensure compliance and enhance existing procedures.
BiopharmaBiotechnologyGeneticsMedical
Responsibilities
Lead the QMS Program, specifically the deviation, CAPA, & change control programs
Develop, improve, and administer the QMS Program
Act as Kivo QMS business administrator
Provide subject matter expertise to improve the QMS
Develop and improve Quality department procedures
Train new users on Kivo QMS
Ensure compliance with approved CRISPR procedures as they relate to the creation and approval of QMS records
Coordinate periodic review of QMS records
Generate metrics to ensure on-time record closure and identify corrective actions
Develop and present QMS metrics to management
Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions
Meet with QMS record owners and participants to ensure proper system usage
Support internal and external audits related to the QMS
Enhance the Quality Culture by being a proactive and professional resource for the business
Qualification
Required
Minimum of 10+ years' experience in related Biopharmaceutical QMS roles
Strong organizational skills and attention to detail
Strong interpersonal skills
Computer skills and previous experience with eQMS
Ability to provide subject matter expertise regarding QMS implementation and administration
Systems Administration experience
Preferred
Experience in Biopharmaceutical QA and/or Quality System improvement roles
BA or BS is preferred though long-time experience in QA may be acceptable
MS or advanced degree
Experience with Gene Therapy / Cell Therapy products
Previous experience with Kivo QMS
Computer System validation experience
Entrepreneurial and results driven
Project Management experience
MS Office proficiency
Benefits
Bonus
Equity
Benefits
Company
CRISPR Therapeutics
CRISPR Therapeutics is focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.
201-500 employees
H1B Sponsorship
CRISPR Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (25)
2023 (16)
2022 (18)
2021 (13)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$407MKey Investors
EcoR1 CapitalBill & Melinda Gates FoundationVersant Ventures
2024-02-13Post Ipo Equity· $280M
2020-12-14Grant
2016-10-19IPO
Leadership Team
Raju Prasad
Chief Financial Officer
Naimish Patel
Chief Medical Officer
Recent News
MarketScreener
2026-01-03
2025-12-26
Company data provided by crunchbase