Quality Management System – /Qualio Lead @ Ginkgo Bioworks

Quality Management System – /Qualio Lead

Qms

Posted on 12/13/2022

INACTIVE

501-1,000 employees

Website

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.

Locations

Dorchester, Boston, MA, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Desired Skills

HTML/CSS

Management

Communications

Responsibilities

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

Our mission is to make biology easier to engineer. Ginkgo is constructing, editing, and redesigning the living world in order to answer the globe’s growing challenges in health, energy, food, materials, and more. Our bioengineers make use of an in-house automated foundry for designing and building new organisms.

The Quality Management System (QMS)/Qualio Lead will manage the Ginkgo QMS and support the SOP development process across Ginkgo. You will manage the maintenance and deployment of the Quality Management System by partnering with functional groups and being the point of contact for our vendor. As a Quality Lead, you will ensure that the QMS is meeting the needs of Ginkgo, that corresponding templates are appropriate and corporate standards are being followed across Ginkgo in regards to SOP creation, execution and compliance.

Responsibilities

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

Preferred Capabilities and Experience

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

To learn more about Ginkgo, visit www.ginkgobioworks.com/press/ or check out some curated press below:

What is it really like to take your company public via a SPAC? One Boston biotech shares its journey (Fortune)

Ginkgo Bioworks resizes the definition of going big in biotech, raising $2.5B in a record SPAC deal that weighs in with a whopping $15B-plus valuation (Endpoints News)

Ginkgo Bioworks CEO on scaling up Covid-19 testing: ‘If we try, we can win’ (CNBC)

Ginkgo raises $70 million to ramp up COVID-19 testing for employers, universities (Boston Globe)

Ginkgo Bioworks Redirects Its Biotech Platform to Coronavirus (Wall Street Journal)

Ginkgo Bioworks Provides Support on Process Optimization to Moderna for COVID-19 Response (PRNewswire)

The Life Factory: Synthetic Organisms From This $1.4 Billion Startup Will Revolutionize Manufacturing (Forbes)

Synthetic Bio Pioneer Ginkgo Raises $290 Million in New Funding (Bloomberg)

Ginkgo Bioworks raises $350 million fund for biotech spinouts (Reuters)

Can This Company Convince You to Love GMOs? (The Atlantic)

We also feel that it’s important to point out the obvious here – there’s a serious lack of diversity in our industry, and that needs to change. Our goal is to help drive that change. Ginkgo is deeply committed to diversity, equity, and inclusion in all of its practices, especially when it comes to growing our team. Our culture promotes inclusion and embraces how rewarding it is to work with people from all walks of life.

We’re developing a powerful biological engineering platform, so we must remain mindful of the many ways our technology can – and will – impact people around the world. We care about how our platform is used, and having a diverse team to build it gives us the best chance that it’s something we’ll be proud of as it continues to grow. Therefore, it’s critical that we incorporate the diverse voices and visions of all those who play a role in the future of biology.

It is the policy of Ginkgo Bioworks to provide equal employment opportunities to all employees and employment applicants.