Manager, Quality Assurance Operations

Requirements

• 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

Additional Information

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.

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