Job Brief

We are currently embarking on a new chapter at Twelve. As we look to expand our manufacturing facilities we are looking to grow the Quality Assurance team.

The Quality Assurance team at Twelve manages processes verifying the predetermined services and specified requirements. The QA team assists in bridging the process across cross-functional teams. We are the positive regulators validating the desired expectations to ensure Twelve's technological advantages remain sustainable.

The Productization group seeks to develop innovative new manufacturing processes and automation tools to establish Twelve as a world leader in carbon transformation. It is composed of several different teams focused on different aspects of engineering, manufacturing, new product introduction, quality, and customer deployments of our CO2 conversion systems.

The Manager, Quality Systems is responsible for overseeing the Quality Management System including quality control to ensure compliance with regulatory agencies. The position will also be responsible for managing the quality processes for different lots of reagents, records, quality control testing and processes as it relates to validations and daily use in R&D, Productization, and Manufacturing. The position will utilize existing protocols and update as needed to improve the quality and efficiency of R&D and product development. The ideal candidate will have a background in quality management systems for product development and manufacturing.

What you will do

• Responsible for performing impact assessments when new enhancements are requested, as well as documenting the assessment within applicable change control.
• Document detailed business processes and business requirements by working with Quality stakeholders at manufacturing and product release sites.
• Facilitate inspections and audits with regulatory agencies and perform appropriate follow-up responses to findings.
• Support and guide QA staff to ensure alignment with the overall quality goals and objectives.
• Manage day-to-day activities related to the Quality Operations department including process owner for administration of the site ERP system, environmental monitoring program, and cleaning surveillance programs.
• Generate strategic plans to drive continuous improvement in Quality Operations at the site and empower the team to execute on those plans to meet business objectives. This includes both large- and small-scale capital projects to support compliance and capacity.
• Accountable for all aspects of projects assigned to the Quality Operations department including but not limited to establishment of clear objectives, planning and scheduling, data trending and analysis, cost assessment, training, implementation, reporting, etc.
• Training, coaching and career development of Quality Operations department

Who you are

• Bachelor’s Degree in Chemistry, Biology, or related technical field.
• 8 years related work experience, preferably from a highly regulated industry
• 3 years people management experience.
• Experience with QMS or ERP systems

Twelve Benefits

• Medical, dental, and vision coverage
• Paid sick days and vacation
• Competitive salary and equity compensation commensurate with experience
• Diverse and inclusive work environment