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Senior Quality Systems Specialist
Job Location:
Job Location:
Cambridge, MA - USA
Yearly Salary:
$ 107100 - 138600
Yearly Salary:
Posted:
21 August 2026 (13 days ago)
Posted:
Application Deadline:
18 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
About eGenesis
eGenesis is aclinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Companys proprietary genome engineering platform enables extensive multiplex gene edits to remove key biological barriers add protective human transgenes and inactivate endogenous retroviruses. EGEN-2784 agenetically engineered porcine kidney is the Companys lead program and is currently being evaluated in amulti-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge MA.
At eGenesis ourcorevaluesinnovation collaboration compassion resilience and passionare 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 compassionfor 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
- Bachelors 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
$107100 - $138600 a year
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
Senior IC
