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. This role plays a key role in establishing the Supplier Quality System including but not limited to SOP and Specification development, Quality Agreements, Risk Assessments, Supplier Auditing and Supplier Change Notifications.

FUJIFILM Diosynth Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

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

Minimum Requirements:

• Bachelor’s Degree in Life Sciences or Engineering with 8+ years of applicable experience OR
• Masters in Life Sciences or Engineering and 6+ years of applicable experience OR
• PhD in Life Sciences or Engineering and 4+ years of applicable
• 4+ years of experience working in a GMP regulated environment
• Prior Experience and Knowledge of pharmaceutical industry and regulations
• Proficient in MS Office suite

Preferred Requirements:

• Previous experience of Smartsheet, Track wise, Master Control, Veeva and/or Kneat validation software
• Experience conducting internal audits

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 30 minutes.

Ability to sit for prolonged periods of time up to 120 minutes. 

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

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

Ability to conduct work that includes moving objects up to 10 pounds.

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.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).