Senior Quality Systems Specialist

eGenesis; Cambridge (MA); On-site; USD 107,000 - 139,000; Full time

Job summary

eGenesis, a Cambridge-based biotech company, is hiring a Senior Quality Systems Specialist to bolster QA across GMP manufacturing and testing. The role reports to the Associate Director of Quality Systems and requires cross-functional collaboration across the organization, located in Cambridge, MA.

You will drive quality processes, manage deviations and CAPAs, oversee documentation and training programs, and contribute to quality metrics and regulatory compliance in a fast-paced environment.

Qualifications

• Bachelor’s degree in a scientific or operational discipline relevant to life sciences or biopharma with 5+ years combined of quality system management experience.
• Non-degreed candidates with 7+ years combined GLP/GMP 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 using QA software tools and electronic Quality Management Systems (eQMS) is a plus.

Responsibilities

• Developing, implementing, and maintaining processes to support QA oversight for manufacturing of material for clinical studies.
• Initiate, support and manage deviations and CAPAs ensuring timely closure across all sites.
• Administer the Electronic Laboratory Notebook for issuance and execution of Batch Records and Test Methods.
• Manage documentation (archival of records, document change controls).
• Coordinate organization training, manage training matrices, and develop the Training Program.
• Participate in cross-functional teams to resolve quality issues impacting manufacturing.
• Develop, trend, and report Quality Metrics for the area of responsibility.
• Support policy, process, procedures, and controls to conform to cGMP and regulatory guidelines.
• Provide QA support to Development, Manufacturing, QC, and other cross-functional teams.

Skills

Quality management knowledge

CAPA processes

Audit procedures

Analytical skills

Communication skills

eQMS proficiency

Education

Bachelor’s degree in life sciences/operational discipline

Non-degreed with 7+ years GLP/GMP quality systems

Tools

Qualio

Veeva

Benchling

eQMS tools

Job description

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, 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, ourcorevalues—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

$107,100 - $138,600 a year