QA Sr Engineer (Quality PM - Operational Readiness & Strategic Initiatives)

Overview

Join us

 

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

About This Role

 

We are looking for a highly motivated QA Senior Engineer who can work directly with our Quality Leadership team on project and Operational Readiness for QA and QC. In this role you will be a key participant in our journey to establish the largest end-to-end cell culture CDMO facility in North America. The role will focus on coordination of deliverables related to project milestones, driving strategic initiatives together with the whole Quality function, budget oversight as well as executable activities related to the global Quality function.

 

You have strong communication skills that you use to drive stakeholder alignment through trust and collaboration. Having a strong Quality background, you will get involved in strategic initiatives and once the site is operational this role will have the responsibility of driving operational excellence and continuous improvements initiatives together with the site and Global Quality functions. The role covers supporting all aspects of the Quality unit.

You will report to the site Quality Head of QA/QC and Regulatory.

 

Experience Fujifilm Diosynth Biotechnologies – Holly Springs for yourself! 

External US

What You’ll Do 

• Support Quality leadership team with facilitation of meetings including presentations and communication of key milestone deliverables for internal and external stakeholders
• Manage operational and executable deliverables for the Quality Workstreams in close collaboration with the whole Quality function
• Facilitate Quality Readiness activities in collaboration with PMO (Project Management Organization) for systems, processes, and talent transfer including communication material
• Support Quality function with financial owners’ cost overviews to assist with budget controls
• Assist with planning and executing strategies including tactical implementation plans
• With a curious mindset, actively seek opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• This role and the associated responsibilities will develop as the project matures and startup activities evolve into operations

Who You Are

 

Looking for someone who can support Quality leadership team with facilitation of meetings including presentations and communication of key milestone deliverables for internal and external stakeholders

 

Basic Requirements

 

We are looking for a candidate with the following background and skill sets:

• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
• BS/BA and 11+ years of applicable experience, or MS and 8+ years of applicable experience, or PhD and 6+ years of applicable experience
• Experience in cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility is required.
• High level of familiarity with quality systems and related automation, manufacturing & IT Systems and methodologies is preferred
• Excellent oral and written communications skills and fluency in English

 Preferred Requirements 

• Experience in the pharmaceutical industry is required
• Experience with Smartsheet, OneNote, Microsoft Suite programs preferred
• Experience in a cGMP facility or working with FDA regulations preferred
• Occasional opportunity for International and/or Domestic travel may be available
• Training and/or familiarity with Quality Risk Management principles preferred

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identi