CRISPR Therapeutics · 2 days ago
Senior Manager, Quality Validation
Framingham, MA
Full-time
Onsite
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 Validation is responsible for supporting the Validation and Compliance Program at the CRISPR Therapeutics GMP facility, including leading commissioning activities and ensuring compliance with validation processes.
BiopharmaBiotechnologyGeneticsMedical
Responsibilities
Lead commissioning activities for facility/utilities and onboarding of new equipment to be installed in support of GMP operations
Reviewing and Approving Validation Lifecycle documentation; User Requirements, Functional Requirements Specifications, Design Specifications/Qualifications (DQs), Installation Qualifications (IQs), Operational Qualifications (OQs) and Performance Qualifications (PQs)
Supporting the development and implementation of processes aimed to support a compliant, robust and sustainable lifecycle for; facilities/utilities and equipment, computer systems, shipping, analytical methods, cleaning and process
Author/Lead development of controlled documents such as policies, processes, and procedures associated with governing the validation program
Lead the implementation of validation/qualification strategies and serve as a Subject Matter Expert
Performing gap analyses on processes, systems, and practices and recommending and implementing corrective actions and improvements including requalification/revalidation exercises
Approving preventive maintenance/calibration, work orders for facilities/utilities and equipment
Leading deviations, investigations, CAPAs, and Change Controls associated to facilities/utilities and equipment
Reviewing and approving; deviation investigations, Corrective and Preventative Actions (CAPAs), Change Controls and Laboratory Investigations
Ensuring CRISPR’s facilities/utilities and equipment processes are maintained in a state of inspection readiness
Participating in supplier qualification audits and supporting internal audits and regulatory inspections
Gathering, preparing, and reporting relevant Quality Metrics
Key internal partners include Quality Assurance, Manufacturing, Facilities, Quality Control, MSAT and Supply Chain
Qualification
Required
Bachelor of Science with experience in qualification, validation or compliance in a highly regulated GMP regulated environment
10+ years of relevant experience
Experience in the development, execution, and approval of DQs, IQs, OQs, and PQs is preferred
Experience in deviation investigation, corrective action and change control is expected
Proficiency with environmental and utilities monitoring principles
Experience with implementation of electronic system(s) to ensure compliance
Excellent written and verbal communication skills with the ability to communicate cross-functionally
Innovation and strategic compliance skills including identification and implementation of best practices
Ability to organize and prioritize workload to meet deadlines and company's objectives
Ability to work independently and within cross-functional teams
Ability to mentor less experienced staff members
Preferred
Prior experience in cell and gene therapy
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
2026-01-13
The Motley Fool
2026-01-13
Company data provided by crunchbase