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 Manager, Quality Systems to join their growing Quality organization. This person will be onsite at our award winning BaseCamp location (Waltham, MA) working closely with QA colleagues responsible for quality operations to provide support for ElevateBio’s internal and external stakeholders related to GMP operations. The Manager, Quality Systems is responsible for the implementation and oversight of events/investigations, CAPAs, product complaints, and change controls.

Here’s What You’ll Do:

  • Plan, support, and manage continuous improvement projects in support of events, CAPAs, change control, product complaints, etc.
  • Provide support and leadership for eQMS scope definition, planning, communication, design, and implementation
  • Conduct QA reviews in support of events/investigations, CAPAs, product complaints, and change controls
  • Support training of functional areas and development of appropriate training for personnel involved in the execution of Quality System processes
  • Coordinate and generate quality metrics in support of periodic quality management review and initiatives to drive for continuous improvements
  • Promote a quality culture by supporting innovation, teamwork and efficiency within the organization
  • Support regulatory inspection readiness activities
  • Develop and implement standards, policies, and procedures for GxP regulatory compliance

Requirements:

  • Minimum of 5 years of relevant Quality experience in biotech industry, preferred cell & gene therapy, early and late-stage development also preferred
  • Demonstrated experience in the development, implementation, and assessment of quality/compliance programs for GxPs, FDA, EMA regulations, guidance
  • Microsoft Office and Veeva Vault Quality Suite experience 
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations

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.

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