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Position Overview

The Principal Quality Officer, (FUJIFILM Life Sciences) FFLS Corporate Quality Office is proactive senior level position designed to provide proactive compliance oversight through advisory audits, data-driven insights, and collaborative support at FUJIFILM Life Sciences platform level.

By fostering transparency, learning, and risk awareness, the FFLS Corporate Quality Office assists FFLS companies turn audits into opportunities for growth while maintaining consistency, accountability, and regulatory excellence across the organization.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies and help make 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.

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

Job Description

Principal Accountabilities:

+ Auditing: Prepare and conduct FFLS Group Quality Audits (e.g. as a proactive tool for integrating new companies/sites; supporting those without recent Third Party Audits; and addressing sites exceeding agreed action limits).

+ Auditing: Peer-review colleagues’ audit reporting.

+ Auditing: Support companies/sites with consultative audits building understanding of compliance requirements and best practices through training as needed.

+ Quality Oversight: Collect and analyze compliance data creating the bi-annual Quality Health Oversight Report providing senior leadership with a structured compliance status overview.

+ Quality Oversight: Analyze Third Party Audit/Inspection outcomes to provide a comprehensive overview of compliance trends, recurring challenges and potential risks across FFLS companies.

+ Strategic Insights: Offer strategic recommendations and assist in identifying process improvement opportunities and innovative solutions. Engage in high-level strategic discussions to drive continuous improvement initiatives. Independent reviewer and authority responses and corrective actions as applicable, ensuring alignment with compliance expectations.

+ Information Management & Presentation Development: Synthesize information to support briefings and presentations. Transform complex data into impactful presentations for various audiences, including executive leadership and cross-functional teams. Convey key messages and strategic initiatives effectively.

+ Effective Communication: Ensure translation of FFLS Corporate Quality vision and goals into actionable directives. Facilitate team alignment by maintaining clear and efficient communication channels.

+ Interpersonal Skills: Foster strong working relationships across all organizational levels. Collaborate with teams and stakeholders to drive alignment, foster teamwork and motivate the organization.

+ Independent Work: Operate autonomously, taking ownership of tasks and projects. Execute initiatives with minimal guidance, making informed decisions.

+ All other duties as assigned.

Minimum Education and Experience Required:

+ Master’s degree in Natural Sciences, Life Sciences or similar with 12+ years within GxP from the biotech/pharmaceutical industry and extensive knowledge of relevant regulatory requirements OR 15+ years experience within GxP from the biotech/pharmaceutical industry and extensive knowledge of relevant regulatory environments.

+ Minimum of 5 years as an Experienced GxP Lead Auditor

+ Excellent understanding of business, value chain, and pharmaceutical industry as well as strong stakeholder and collaboration skills in a multinational context.

Knowledge, Skills and Abilities:

+ Exceptional communication skills, both written and verbal, with the ability to convey complex ideas clearly and concisely.

+ Fluency (verbal and written) in English

+ Strong presentation skills, capable of engaging and influencing diverse audiences.

+ Excellent interpersonal skills and ability to collaborate effectively with cross-functional teams.

+ Understands the importance of involving stakeholders in daily work and interact effectively with senior management.

+ Ability to identify risk areas, manage time effectively, and reach conclusions while being flexible and adaptable to change.

+ Strong analytical skills with an eye for detail combined with the ability to extract and apply into a tactical and strategic context.

+ Self-motivated and able to work independently with minimal supervision.

+ Professionalism, tact, and discretion in handling confidential matters.

The salary range for this US remote role is $187,000 to $294,000/yr. dependent on a number of factors including but not limited to experience and geographic location.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agenciesto 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 agencieswere 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 agencyengagement process is hired, no fee or payment of any kind will be paid.

EEO Information

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.

ADA Information

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 ([email protected]).

**Job Locations** _US-NC-Raleigh Triangle Park_

**Posted Date** _5 days ago_ _(5/22/2025 10:00 AM)_

**_Requisition ID_** _2025-34135_

**_Category_** _Quality Assurance_

**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_