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.

POSITION SUMMARY

The Manager of Quality Assurance (QA) is accountable for overseeing the GMP production operations to be conducted at Genesis. This will include supporting the manufacturing operations, facilities/utilities/systems/equipment lifecycle, and supporting all the records generated as part of the manufacturing operations to maintain the GMP facility.

This role will be responsible for ensuring compliance to GMP standards at eGenesis. This position reports to the Senior Manager of Quality and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the organization.

PRIMARY RESPONSIBILITIES

Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of drug product to be used in clinical studies

Supporting the development of policies, processes, procedures, and controls ensuring that facility operations conform to established cGMP standards and regulatory requirements and guidelines

Supporting the qualification activities associated with the implementation and release of systems, utilities, facility areas (i.e., manufacturing suites), and equipment onboarding/maintenance for the facility

Supporting day-to-day QA activities associated with manufacturing of drug product

Releasing manufacturing suites and batch/product changeovers for continuation of manufacturing activities

Participating in cross-functional teams to resolve quality-related issues impacting manufacturing activities

Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs associated with the operations at the manufacturing facility

Evaluating and approving proposed process changes and improvements in the manufacturing area, ensuring that appropriate risk assessments are conducted and proposed changes/improvements are consistent with applicable regulatory guidelines

Supporting investigations associated with critical or major manufacturing deviations and providing the necessary guidance to authorize manufacturing operations, as applicable

Authoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.)

Participating in supplier qualification audits and supporting internal audits and regulatory inspections, as needed

Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility

Maintaining the QA Operations function in a state of compliance and inspection readiness

BASIC QUALIFICATIONS

B.S./M.S. in Life Sciences or related field with 5+ years of experience, including leadership, in GMP Quality Assurance

Experience with QA and GMP compliance in clinical biologics products

Experience providing QA oversight to manufacturing operations in a pharmaceutical/ biotechnology environment

Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures

Experience with implementation of electronic system(s) to ensure compliance in 21CFR Part 11 and other applicable regulations

Ability to organize and prioritize workload to meet deadlines and company objectives.

Ability to work independently and within cross-functional teams

Knowledge of FDA/EMA/ICH regulations and guidelines regarding clinical production and supply of biopharmaceutics

LEADERSHIP QUALIFICATIONS

Organizational, staff mentorship, and time management skills with attention to details

Handling multiple assignments in a fast-paced environment with changing priorities

Independent development and execution of work plans with minimal supervision

Strong analytical problem-solving, and critical thinking skills

Excellent written and verbal communication skills with the ability to communicate effectively

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