Senior Quality Systems Specialist

Egenesisbio; Cambridge (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

eGenesis, a Cambridge, MA biopharma company, is seeking a Senior Quality Systems Specialist to support QA systems across GMP manufacturing and testing. The role reports to the Associate Director of Quality Systems and requires cross-functional collaboration within the organization.

The position is based in Cambridge, MA. Key responsibilities include developing QA oversight processes, managing deviations and CAPAs, administering ELN, and advancing training and quality metrics.

Qualifications

• Bachelor’s degree in a scientific or operational discipline with 5+ years QA quality systems experience
• Non-degreed candidates with 7+ years relevant GLP/GMP QA quality systems experience will be considered
• Knowledge of Quality Management Systems (QMS), CAPA processes, and audit procedures
• Familiarity with ISO, FDA, cGMP regulations and standards
• Strong analytical, problem-solving, and communication skills
• Proficiency in QA software tools and eQMS is a plus

Responsibilities

• Developing, implementing, and maintaining QA oversight processes for manufacturing materials used in clinical studies
• Initiate, support and manage deviations and CAPAs with timely closure across sites
• Administer Electronic Laboratory Notebook for batch records and test methods
• Responsible for Documentation Management (archival of physical records, change controls)
• Coordinate organizational training; manage training matrices and metrics
• Participate in cross-functional teams to resolve quality issues impacting manufacturing
• Develop, trend and report Quality Metrics for area of responsibility
• Support development of policies, procedures, and controls per cGMP and regulatory guidelines
• Provide QA support to Development, Manufacturing, and Quality Control teams
• Mentor staff on regulatory requirements and quality systems usage
• Implement process improvements to enhance compliance and product quality
• Support in reviewing/approving records (Forms, Logbooks, Master Batch Records)
• Handle special QA projects as assigned by QA Management

Skills

Analytical

Problem-solving

Communication

Education

Bachelor’s degree in life sciences or related

7+ years GLP/GMP QA quality systems experience with no degree

Tools

Qualio

Veeva

Benchling

Job description

About eGenesis

eGenesis is aclinical-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, agenetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in amulti-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.

• 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

• 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

• Experience in Qualio, Veeva and/or Benchling
• Experience in a start-up or small company environment