The Role
Support QA to implement and manage quality systems for GMP manufacturing and testing across sites. Manage deviations and CAPAs, administer ELN for batch records and test methods, handle documentation and training programs, develop and report quality metrics, support cGMP/ISO/FDA-compliant policies and procedures, mentor staff, review executed records, and drive process improvements and special QA projects.
Summary Generated by Built In
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
At eGenesis, our core values—innovation, collaboration, compassion, resilience, and passion—are at the center of how we work. We engineer hope and bring passion to everything we do. We collaborate and learn from one another, combining diverse expertise to tackle complex challenges. We innovate boldly, pushing boundaries and science to new heights. where no pig organ has gone before. With resilience, we navigate challenges and celebrate progress together. And in all we do, we lead with compassion—for our patients, our people, and our pigs.
POSITION SUMMARY
The Senior Quality Systems Specialist will be supporting the QA team to implement and manage Quality Systems supporting GMP Manufacturing and Testing across all eGenesis locations.
This position reports to the Associate Director of Quality Systems and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the Organization. This position will be in Cambridge, MA.
RESPONSIBILITIES
- Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of material to be used in clinical studies
- Ability to initiate, support and manage deviations and CAPAs ensuring timely closure across all sites
- Management and Administration of the Electronic Laboratory Notebook used for issuance and execution of Batch Records and Test Methods
- Responsible for Documentation Management (archival of physical records, management of Document Change Controls etc.)
- Responsible for Organization Training including administering training, managing training matrices, trending metrics and further developing the Training Program
- Participating in cross-functional teams to resolve quality related issues impacting manufacturing activities
- Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility
- Supporting the development of policies, processes, procedures, and controls ensuring they conform to established cGMP standards and regulatory requirements and guidelines
- Provide Quality Assurance support to many cross functional teams including Development, Manufacturing, Quality Control departments
- Provide mentoring and training to staff that are new to regulatory requirements and to facilitate their use of established quality systems
- Implement process improvements to enhance compliance and improve method and product quality processes (e.g. process tools creation, SOP revision, or enterprise systems implementation)
- Provide Quality Assurance support in reviewing/approving executed records in needed areas (Forms, Logbooks, Master Batch Records etc.)
- Perform duties regarding special projects, as assigned by QA Management
TECHNICAL QUALIFICATIONS
- Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management
- Non-degreed candidates with 7+ years combined of relevant GLP/GMP quality systems experience will be considered
- Knowledge of Quality Management Systems (QMS), CAPA processes, and audit procedures
- Familiarity with relevant regulations and standards (e.g., ISO, FDA, cGMP)
- Strong analytical, problem-solving, and communication skills
- Proficiency in using QA software tools and electronic Quality Management Systems (eQMS) is a plus
PREFERRED QUALIFICATIONS
- Experience in Qualio, Veeva and/or Benchling
- Experience in a start-up or small company environment
Skills Required
- Bachelor's degree in a scientific or operational discipline relevant to life sciences or biopharma with 5+ years combined experience in quality system management
- Non-degreed candidates with 7+ years combined relevant GLP/GMP quality systems experience (alternative to degree)
- Experience managing Quality Management Systems (QMS), CAPA processes, and audit procedures
- Familiarity with relevant regulations and standards (e.g., ISO, FDA, cGMP)
- Strong analytical, problem-solving, and communication skills
- Proficiency with QA software tools and electronic Quality Management Systems (eQMS)
- Experience with Qualio, Veeva and/or Benchling
- Experience in a start-up or small company environment
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The Company
What We Do
eGenesis is revolutionizing the field of transplantation with an unparalleled, multiplexed gene editing platform for the development of human-compatible organs, tissues and cells. Harnessing the latest gene-editing techniques, eGenesis has the capability to solve the global organ crisis by providing an alternative to allotransplantation. eGenesis is uniquely positioned to reinvigorate the field of xenotransplantation by addressing both the key virology and immunology hurdles that have impeded its advancement to date and provide commercially-viable products to save and enhance the lives of patients in need.
