Manager, Quality Assurance Operations

The Manager of Quality Assurance (QA) oversees GMP production operations, ensuring compliance to GMP standards at eGenesis. This role is responsible for developing, implementing, and maintaining processes to support QA oversight for manufacturing of drug product, and supporting the development of policies and procedures to conform to established cGMP standards and regulatory requirements.

Requirements

• B.S./M.S. in Life Sciences or related field
• 5+ years of experience 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
• 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

Benefits

• Competitive salary
• Comprehensive benefits package
• Opportunities for professional growth and development
• Collaborative and dynamic work environment