Quality Management System – /Qualio Lead
Posted on 12/13/2022
Ginkgo Bioworks

501-1,000 employees

Biological engineering products developer
Company Overview
Ginkgo Bioworks’ mission is to make biology easier to engineer. The company designs custom microorganisms for customers across multiple industries.
Dorchester, Boston, MA, USA
Experience Level
Desired Skills
  • SME (subject matter expert) and system owner for Quality Management System Implementation and Oversight
  • Experience managing teams, programs, or directing allocation of resources
  • Quality Oversight in maintenance of QMS: (1) Work cross functionally with IT Administrators and team leads to identify Champions, assign licenses, and provide training resources (2) Support with creating user groups within the QMS system to gain familiarity exercising document control such as template management and document archival (3) Support the periodic review of General QMS policies and processes (4) Resolve problems, identify trends and make system improvements
  • Collaborate with external stakeholders to identify gaps and resolve QMS related issues
  • Support Quality System stakeholders with workflow management and electronic system usage
  • Retain ownership and support deployment of training and onboarding of various teams (Foundry, Codebase etc.) onto the QMS
  • Collaborate with Foundry Leads and Quality Champions from departments to define and structure documentation and training needs per project and team
  • Identify and facilitate continuous improvement efforts
  • Promote QMS Best Practice and encourage standardization of QMS usage
  • Build, maintain and implement project plans and timelines to ensure that results within the project plan are met and on-time
  • Identify and implement new solutions to improve tracking, planning and collaboration; develop tools to improve efficiency
  • Represent Foundational Quality/Quality on new projects/teams as needed
  • Escalate, to management, any problems or unresolved issues that could affect the timely completion or quality of work, from a documentation perspective
Desired Qualifications
  • Experience with Quality Management Systems and/or Document Management Systems
  • Interpersonal skills, written and verbal communication
  • Ability to defend processes and decisions during audits or implementation
  • Ability to evaluate quality matters through risk based approaches
  • Open to learning
  • Ability to work independently and in a team environment