Principal Quality Officer

Position Overview

The Principal Quality Officer, FFLS Corporate Quality Office is proactive seniorlevel 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

Job Description

Key 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 af 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

Education & Experience

• Master’s degree in Natural Science or similar

• Profound experience (+10 years) within GxP from the biotech/pharmaceutical industry and extensive knowledge of relevant regulatory requirements

• Experienced GxP Lead Auditor (+5-10 years) 

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

• Fluency in English, both written and spoken

Scope & Decision Making

• Plays an important role in ensuring the effectiveness of the FFLS Corporate Quality Office providing FFLS HQ leadership proactive compliance oversight through advisory audits, data-driven insights, and collaborative support

• Directly impacts the efficiency and effectiveness of the FFLS Corporate Quality Office at platform level

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  Directly influences improvement of decision-making based on consolidated compliance data and trend analysis. Ensures enhanced efficiency through structured data analysis and reporting and proactive auditing

• Requires a high degree of decisiveness and prioritization to resolve complex issues and manage multiple tasks simultaneously. 

  Operates with significant autonomy, making informed decisions and providing recommendations with minimal supervision

Knowledge & Skills

• Requires a high degree of decisiveness and prioritization to resolve complex issues and manage multiple tasks simultaneously 
• Operates with significant autonomy, making informed decisions and providing recommendations with minimal supervision

• Strong presentation skills, capable of engaging and influencing diverse audiences

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

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

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  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

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  Self-motivated and able to work independently with minimal supervision

• Professionalism, tact, and discretion in handling confidential matters