Full-Time

Manager – Quality Assurance Operations

Viral Vector

Confirmed live in the last 24 hours

ElevateBio

ElevateBio

201-500 employees

Cell and gene therapy manufacturing platform

Industrial & Manufacturing

Senior

Waltham, MA, USA

Required Skills
Management
Quality Assurance (QA)
Requirements
  • BA/BS degree with 7+ years of experience in a pharmaceutical, biotechnology or biologics operation with 5 of those being within Quality.
  • 2+ years of experience managing a team
  • Experience in Viral Vectors, Cellular and Gene Therapy Products is desired.
  • Working knowledge and ability to apply GMPs.
  • Strong teamwork and collaborative skills.
  • Experience with manufacturing investigations, deviations, and CAPA.
  • Experience with change control practices and strategies.
  • Strong knowledge with aseptic manufacturing processes is preferred.
  • Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.
Responsibilities
  • Develop and coach team members for fostering a collaborative environment and enabling performance.
  • Ensure timely delivery of final product through performance of disposition activities.
  • Serve as Quality Point-of-Contact for a client program.
  • Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.
  • Perform receipt and disposition of incoming patient apheresis material.
  • Perform issuance verification of production documents and labels, to meet production schedule.
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Ensure all product-related Deviations are initiated, investigated, and resolved.
  • Ensure that associated CAPAs are initiated and resolved.
  • Perform review of quality records including lab investigations, work orders, and change controls.
  • Ownership of quality records such as impact assessments, major deviations, CAPAs and change controls.
  • Identify compliance risks and escalate the issues to appropriate levels of management for timely resolution.

ElevateBio stands out as a compelling workplace due to its specialized focus on cell and gene therapies, a cutting-edge area of medical science. The company's integrated platforms for gene editing and various forms of cellular engineering, alongside their purpose-built manufacturing platform, BaseCamp, highlight their commitment to process innovation and adherence to cGMP manufacturing standards. This not only positions ElevateBio at the forefront of biotechnological advancements but also offers its employees a dynamic and technically enriching environment to develop their careers.

Company Stage

Series D

Total Funding

$1.2B

Headquarters

Waltham, Massachusetts

Founded

2017

Growth & Insights
Headcount

6 month growth

1%

1 year growth

6%

2 year growth

32%