Senior Manager, Quality Operations Details

Senior Manager, Quality Operations

ElevateBio - Waltham, MA

Employment Type : Full-Time

ElevateBio is a cell and gene therapy technology company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies.

The Role:

ElevateBio is looking for a Manager / Senior Manager, Quality Operations to join the growing Quality group. In this role, the individual will be responsible for providing appropriate oversight to ensure cGMP compliance of clinical cell therapy and regenerative medicine products produced by ElevateBio. The Manager / Senior Manager provides a link between operations and the various quality systems. The primary responsibility is to lead the QA support of ElevateBio programs, including directly supporting Operations on the floor and real-time, on-line batch record QA review and approval.

Here's What You'll Do:

• Partner with relevant internal and external teams to highlight potential quality issues (g., during process transfer, manufacturing, and testing); identify/execute strategies to effectively manage them
• Review and approve risk assessments, change controls, deviations, investigations, and associated CAPAs; lead complaint investigations
• Ensure timely resolution and escalation of issues within the operational areas
• Ensure Cell Therapy and Regenerative Medicine products are manufactured in compliance with regulatory and GMP guidelines
• Perform lot closure and disposition activities
• Ensure approval and timely delivery of final product
• Collaborate within QA and cross functionally on projects as applicable
• Manage QA Operations associates

Requirements:

• BA/BS degree with 6-8+ years of QA experience in a pharmaceutical, biotechnology or biologics operation
• Experience in Viral Vectors, Cellular & Gene Therapy Products
• Working knowledge and ability to apply GMPs
• Strong teamwork and collaborative skills
• Experience with manufacturing investigations, deviations, and CAPA
• Strong knowledge with aseptic manufacturing processes
• Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems

Why join ElevateBio?

ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

Our Vision:
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.