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  Sr. Quality Specialist, to join their growing QA systems group. In this role, the individual will manage the Electronic Document Management System (EDMS), to ensure all ElevateBio’s record and documentation systems are in compliance with US and international regulations, laws, and guidelines. The Senior Quality Specialist will be accountable for management of the EDMS, as well as support training, audits and inspections, and continuous improvement.

 

Here’s What You’ll Do:

  • Support the management of ElevateBio’s GxP Electronic Documentation Management Systems (EDMS)
  • Coordinate and support the creation, revision, distribution, and maintenance of controlled documentation (i.e., SOPs, regulatory submission documents, trial master file documentation, etc.)
  • Work directly with the QA and Regulatory departments and other ElevateBio departments to revise and track controlled documents and records to meet timelines. Provide status updates and reminders when necessary
  • Ensures basic grammatical accuracy and completeness when revising documents
  • Oversee document change control processes and drive to closure
  • Conducts internal audits of the electronic document management system and documents where needed to ensure compliance to applicable ElevateBio Policies and SOPs
  • Support client and regulatory (FDA, EMA), inspections when necessary
  • Compile and provide applicable metrics for periodic Management review
  • Promote a Quality Culture by supporting innovation, teamwork and efficiency within the organization

Requirements:

  • Bachelor’s Degree and +5 years of experience with GxP in the pharmaceutical, biologic or medical device industries
  • Prior experience with an Electronic Document Management Systems and Trial Master Files
  • Experience with the establishment of an eTMF using the Trial Master File Reference Model
  • Microsoft Word and Microsoft Access experience
  • Knowledge of both domestic and international GMP, GCP and other relevant regulations.
  • A team player, who listens effectively and invites response and discussion
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner

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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