Principal Quality Officer

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 datadriven 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.

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. Were growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Were 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 whats possible.

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). 15
• Auditing: Peerreview 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 biannual 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 highlevel 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 crossfunctional 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:

• Masters 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 crossfunctional 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.
• Selfmotivated and able to work independently with minimal supervision.
• Professionalism tact and discretion in handling confidential matters.

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 viaemail 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 committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .