Overview:

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

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.

External US:

About This Role

The Sr. Engineer, Supplier Quality, provides supplier oversight to ensure that suppliers of services or materials to Fujifilm Diosynth Biotechnologies are of the highest quality while conforming to pre-established requirements including cGMPs. This role primarily focuses on supplier quality, working with suppliers to maintain supplier approvals. Initially, this position will be key to the establishing the Supplier Quality System including but not limited to SOP and Specification development, Quality Agreements, Risk Assessments, Supplier Auditing and Supplier Change Notifications. The ability to effectively collaborate, influence, and coordinate amongst suppliers and team members within Supply Chain, Quality Control, and Quality Management is critical to this role.

What You’ll Do

• Prepares, conducts, and reports results of audits of GMP service providers and suppliers of various GMP materials, and internal processes to meet quality compliance requirements.

• Creates and maintains a list of approved suppliers/service providers.

• Establishes and maintain policies, procedures, checklists, self-assessment surveys, and additional forms for the internal and supplier audit programs.

• Monitors raw material supplier quality and works directly with Supply Chain, QA, and suppliers to improve performance.

• Oversees and reports on the progress of audit corrective and preventative actions and audit findings for both the internal and supplier audit programs during Quality Management Meetings.

• Supports Quality management contact with the FDA, EMA and other regulatory authorities worldwide as well as partners regarding quality issues including field alerts, recalls or regulatory actions.

• Supports GMP inspections and audits from both regulatory authorities and partners and supports drafting of follow-up responses for all aspects of the business.

• Supports other GXP functions, as required. 

• Supports and participates in the supplier change notification and supplier complaints.

• Performs other duties, as assigned

Who You Are

You have a collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals. You have excellent oral and written communications skills. You have excellent organizational and critical thinking skills. You have attention to detail and commitment to maintaining the quality standards. You have the ability to multitask and meet deliverables and timelines. You have the ability to be agile and flexible. You have the ability to manage multiple assignments while meeting timelines in a GMP environment. You have an understanding of Data Integrity, and application of 21 CFR Part 820 and Part 11.

Basic Requirements

• Bachelor’s Degree in Life Sciences or Engineering with 9+ years of applicable cGMP experience OR

• Masters in Life Sciences or Engineering and 7+ years of applicable cGMP experience OR

• PhD in Life Sciences or Engineering and 5+ years of applicable cGMP experience

• 5+ years’ experience in a cGMP Quality, in an FDA regulated facility

• Prior Experience and Knowledge of pharmaceutical industry and regulations

• Proficient in of MS Office suite

Preferred Requirements

• Previous experience of Smartsheet, Track wise, Master Control, Veeva and/or Kneat validation software.

• Occasional opportunity for International and/or Domestic travel may be available.

• Experience conducting internal audits.

• Certified ISO 9001 Auditor Training

• ASQ - Certified Quality Auditor

WORKING ENVIRONMENT

PHYSICAL DEMANDS

Ability to stand for prolonged periods of time - 30 Minutes

Ability to sit for prolonged periods of times - 120 Minutes

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

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 identify or any other protected class. If an accommodation to the application process is needed, please email .

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.