Principal Quality Officer

We are looking for a Principal Quality Officer, FUJIFILM Life Sciences (FFLS) Corporate Quality Office. This is a 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.

FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production.

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.
  
  
  

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

• Operate autonomously, taking ownership of tasks and projects. Execute initiatives with minimal guidance, making informed decisions.
• 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.
  
  
  

Please upload your CV latest by April 23rd.

As part of any recruitment process, FUJIFILM Diosynth Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

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 via-email, 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.