Overview

Our goal is to improve lives by restoring or replacing the function of damaged cells, tissues, and organs for patients. BioFabUSA's mission is to develop a highly diverse, competitive, capable and innovative cell, tissue, and organ ecosystem that ensures a low-cost and high-quality domestic healthcare system and domestic leadership in the biofabrication industrial base.

The Impact That You Will Make

Quality Managers are critical to our success. In this role, you will build and support a robust Quality team, ensuring compliance to federal regulations and internal operating procedures at appropriate stages during the development and manufacture of complex biologic products. Reporting to the Director of RA/QA, you will contribute to establishing a world-class Quality department and introduce best practices that are appropriate for our programs.

Your Role

• Manage the daily operational aspects of a biopharmaceutical Quality team
• Identify and capitalize on the strengths and motivations of individuals within the group
• Be a champion for continuous improvement and identify and implement solutions to enhance quality system effectiveness
• Serve as a Quality representative in cross-functional initiatives, providing a compliance-minded perspective
• Execute and track Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls)
• Lead root cause analysis investigations to identify, mitigate, and prevent nonconformances
• Oversee the document control and issuance processes
• Aid in the management review process to ensure the effectiveness of the Quality System
• Develop, review, and approve Quality System SOPs
• Review technical data in support of GLP/GMP operations
• Develop engaging programs to effectively train ARMI personnel
• Review and approve master batch records for GMP Tissue Foundry processes
• Perform line clearances of manufacturing spaces as needed
• Ensure site readiness for audits and regulatory inspections
• Collaborate with Tech Team, Program Management, and external stakeholders to facilitate technical transfer of incoming projects

Your Skills and Experiences

• Bachelor of Science Degree in life sciences or engineering discipline
• Minimum of 5 years of direct work experience in of experience in GMP biotech/pharmaceutical Quality
• Minimum of 2 years of direct Quality management experience
• Knowledge of FDA regulations, especially 21 CFR Part 210 and 211
• Proven ability to lead and motivate highly technical teams and to maintain high morale
• Ability to influence colleagues, clients, and Institute members at all levels in the organization
• Exceptional written and verbal communication skills
• Comfortable leading multiple quality system efforts in a fast-paced, dynamic, and highly collaborative team environment
• Proficient with Microsoft software products, especially formatting within MS Word
• Collaborative attitude, sense of curiosity, and eagerness to impact positive change
• Experience in the CDMO business model is desired