QA Engineer, Quality Risk Management

Fujifilm • Holly Springs, NC

1d

About The Position

The QA Engineer, Quality Risk Management, drives the design, implementation, and continuous improvement of risk-based quality systems across the product lifecycle. The role facilitates structured risk assessments (e.g., FMEA, HACCP), translates risk outputs into controls, verification/validation plans, and monitoring strategies, and maintains risk registers and quality risk metrics. It partners cross-functionally with Manufacturing/Operations, Supply Chain, and Regulatory to enable compliant, data-driven decisions, effective change control, and prioritized CAPA. This position exists to proactively identify, quantify, and mitigate quality risks to safeguard patient/customer safety, ensure product reliability, and maintain compliance with applicable standards and regulations (e.g., ISO 9001/13485, ICH Q9, ISO 14971).
FUJIFILM 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

Requirements

• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR
• MS in Life Sciences or Engineering and 3+ years of applicable experience OR
• PhD in Life Sciences or Engineering and 1+ years of applicable experience
• 3+ years of experience in a GMP environment
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
• High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies

Nice To Haves

• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
• Experience with startup projects or initiatives

Responsibilities

• Leads and facilitates Quality Risk Management (QRM) assessments and workshops to identify, analyze, and address key quality risks/issues; ensures timely escalation and effective risk handling.
• Identifies and assesses risks across operations, designs mitigation strategies, prioritizes risk actions, and communicates progress and outcomes at defined stage gates to drive timely decisions.
• Builds relationships and initiates cross-functional collaboration with key counterparts and stakeholders across FLBN to surface quality risks and define process improvement initiatives.
• Collaborates with and provides direct support to Manufacturing, Facilities, Supply Chain, QC Laboratory Testing, and other stakeholders to implement and sustain QRM processes within established work practices.
• Ensures consistent application of QRM system requirements in alignment with local/global procedures, policies, and applicable regulatory standards (e.g., cGMP).
• Prepares and delivers comprehensive reports on QRM activities; maintains risk registers and quality risk metrics to enable transparent, data-driven decision-making.
• Creates and maintains procedures, work instructions, forms, templates, and related QRM documentation to standardize practices and enhance compliance.
• Manages multiple QRM projects concurrently, balancing scope, priorities, and timelines to meet deliverables.
• Promotes a strong Quality Culture by reinforcing cGMP principles and best practices across departments.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level