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ElevateBio Manager, Quality Systems in Waltham, Massachusetts

Title: Manager, Quality Systems

Location: Waltham, MA

Reports to: Sr. Manager, Quality Assurance

The Role:

ElevateBio is looking for QA Manager, to join their growing Quality Systems group. The individual in this role will work closely with QA colleagues responsible for quality operations to provide support for ElevateBio?s internal and external stakeholders related to GMP operations. The Manager of Quality Systems is responsible for the implementation, and oversight of Events/Investigations, CAPAs, Product Complaints, and Change Controls.

Here?s What You?ll Do:

Under the guidance of the Senior Manager of Quality Systems, the candidate will:

  • 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 drug and/or biologics within the pharmaceutical or biotechnology industry, including early and late-stage development

  • Demonstrated experience in the development, implementation, and assessment of quality/compliance programs for GxPs, FDA, EMA regulations, guidance

  • Experience in Cell and Gene Therapy is preferred

  • Microsoft Office and Veeva Vault Quality Suite experience is preferred

  • 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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