Principal Quality Officer

Company: FUJIFILM Holdings America Corporation
Location: Durham
Posted on: May 7, 2025

Job Description:

Position OverviewThe 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 OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important-and we are looking for talented candidates to join us. We're 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. We're proud to cultivate a culture that will fuel your passion, energy, and drive what FUJIFILM Diosynth Biotechnologies calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FUJIFILM Diosynth Biotechnologies, you determine what's possible.Job DescriptionPrincipal 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). (15%)
• Auditing: Peer-review colleagues' audit reporting. (5%)
• Auditing: Support companies/sites with consultative audits building understanding of compliance requirements and best practices through training as needed. (10%)
• Quality Oversight: Collect and analyze compliance data creating the bi-annual Quality Health Oversight Report providing senior leadership with a structured compliance status overview. (10%)
• Quality Oversight: Analyze Third Party Audit/Inspection outcomes to provide a comprehensive overview of compliance trends, recurring challenges and potential risks across FFLS companies. (10%)
• 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. (10%)
• 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. (10%)
• Effective Communication: Ensure translation of FFLS Corporate Quality vision and goals into actionable directives. Facilitate team alignment by maintaining clear and efficient communication channels. (10%)
• Interpersonal Skills: Foster strong working relationships across all organizational levels. Collaborate with teams and stakeholders to drive alignment, foster teamwork and motivate the organization. (10%)
• Independent Work: Operate autonomously, taking ownership of tasks and projects. Execute initiatives with minimal guidance, making informed decisions. (5%)
• All other duties as assigned. (5%)Minimum Education and Experience Required:
  • Master's degree in Natural Sciences, Life Sciences or similar is required.
  • 10+ years within GxP from the biotech/pharmaceutical industry and extensive knowledge of relevant regulatory requirements.
  • 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.
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Keywords: FUJIFILM Holdings America Corporation, Greenville , Principal Quality Officer, Other , Durham, North Carolina