eGenesis, Inc. · 5 months ago
Senior Manager, Quality Control
Greater Madison Area
Full-time
Onsite
Mid, Senior Level
3+ years expeGenesis, Inc. is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering. They are seeking an experienced and proactive Senior Manager, Quality Control to lead the design, implementation, and continuous improvement of the Environmental Monitoring and Microbiology programs across their GMP manufacturing facilities.
BiopharmaBiotechnologyGeneticsLife ScienceMedical
Responsibilities
Oversee environmental monitoring programs (viable/non-viable air, surface, personnel, water) at REN and MID to ensure compliance with cGMP and regulatory standards (FDA, EU Annex 1)
Lead daily EM operations, data review/trending, excursion management, and CAPA implementation
Drive cross-functional contamination control initiatives and risk mitigation strategies
Act as the primary SME during audits and inspections for EM, contamination control, and microbial trending
Lead the buildout and qualification of the new QC Microbiology lab at the Middleton (MID) site to support in-house EM testing and microbial identification capabilities
Oversee qualification of QC instruments (e.g., incubators, particle counters, ID systems like MALDI-TOF, qPCR), utilities, and workflows supporting microbiology testing
Establish and validate a site-wide water sampling and testing strategy, aligned with regulatory standards and phase-appropriate GMP compliance
Author and/or review protocols and reports related to lab qualification, method validation, and readiness assessments
Directly supervise and mentor QC team members responsible for EM sampling, lab operations, and method execution
Collaborate with QA, Manufacturing, Validation, and Facilities teams to align EM practices and lab readiness with site and program needs
Participate in facility and equipment readiness reviews, CCRB, and project planning meetings to ensure Quality alignment
Support harmonization of QC systems, SOPs, and training across sites for a unified Quality culture
Develop and maintain SOPs, forms, protocols, and work instructions related to EM and QC Microbiology functions
Ensure timely and accurate documentation in LIMS, QMS (e.g., Veeva, Qualio), and related quality systems
Lead or support deviation investigations and change controls related to environmental excursions, water testing, or lab performance
Qualification
Required
BS/MS in microbiology, biology or a related scientific discipline with 3-5 years industry experience in a QC laboratory
Proficient in microbiology methods (plate enumeration, growth promotion, microbial ID, etc.) and aseptic technique needed to perform EM in a GMP environment
Familiarity with regulatory guidance (FDA, EU Annex 1, USP , , , , etc.) and industry best practices
Excellent leadership, communication, and problem-solving skills
The ability to work and lead in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is essential
Effective communication skills, both verbal and written, at all levels and across various functions
Preferred
Experience with digital monitoring tools (e.g., ELLAB, MODA, LIMS) and quality systems such as Veeva is a plus
Company
eGenesis, Inc.
eGenesis is revolutionizing the field of transplantation with an unparalleled, multiplexed gene editing platform for the development of human-compatible organs, tissues and cells.
51-200 employees
H1B Sponsorship
eGenesis, Inc. 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 (4)
2024 (2)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$456MKey Investors
Lux CapitalFresenius Medical Care
2024-09-04Series D· $191M
2021-03-02Series C· $125M
2019-11-07Series B· $100M
Leadership Team
Michael Curtis
President and CEO
Peter Hanson
Chief Operating Officer
Recent News
2026-01-07
2025-12-18
Company data provided by crunchbase