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Senior Manager of Quality Assurance

1 month ago

Cambridge, Massachusetts, United States eGenesis Bio Full time
Job Title: Senior Manager, Quality Assurance Job Summary: At eGenesis Bio, we are seeking a highly skilled Senior Manager, Quality Assurance to oversee our GMP cloning operations and Supplier Management Program. This is a critical role that requires strong leadership, technical expertise, and excellent communication skills. Key Responsibilities: * Develop, implement, and maintain processes to support QA oversight for the manufacturing of cloning material * Support the development of policies, processes, procedures, and controls ensuring compliance with cGMP standards and regulatory requirements * Participate in cross-functional teams to resolve quality-related issues impacting manufacturing activities * Review and approve documentation such as Manufacturing Batch Records, product specifications, change controls, deviations, and CAPAs * Evaluate and approve proposed process changes and improvements in the Manufacturing area * Support investigations associated with critical or major manufacturing deviations * Author, review, and approve internal quality documents Supplier Quality Management Responsibilities: * Manage the Supplier Quality Management Program at eGenesis Bio * Coordinate qualification activities for new vendors and annual audit schedule * Oversee suppliers of raw materials, reagents, equipment, and services supporting operations * Facilitate risk assessments for new materials or services to be introduced in support of eGenesis Bio's operations * Negotiate and maintain Quality Agreements between eGenesis Bio and its suppliers Requirements: * B.S./M.S. in Life Sciences or related field with 8+ 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 * 5+ years of supplier/vendor quality management experience in a GxP regulated environment * Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures * Ability to negotiate and implement Quality Agreements with vendors Leadership Qualifications: * Organizational, staff mentorship, and time management skills with attention to details * Ability to negotiate, influence, and work in a cross-functional environment * 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 About eGenesis Bio: At eGenesis Bio, we aspire to deliver safe and effective human transplantable cells, tissue, and organs utilizing the latest advancements in genome editing. We are committed to excellence in quality, innovation, and customer satisfaction. If you are a motivated and experienced professional looking for a challenging role in a dynamic and growing company, please submit your application.