Experienced Site Quality Review Board manager

Are you a skilled and experienced Quality Assurance specialist eager to join a fast-growing CDMO? Apply for this position where you will be an important part of developing and ensuring our quality aspiration.

We have a unique opportunity for a Site Quality Review Boards Manager who shares our passion, drive, and energy – what we call Genki – to build strong Quality Review Board structure across the Site

The position

You will take on the role as Site Quality Review Board Manager for our site in Hillerød, Denmark. The position is anchored in Quality, but your ability to understand and connect with all departments is key to success. You will provide guidance and support to operations related to quality governance and overview, ensuring the Review Boards create tangible value for operations through clear guidance, solving issues together, creating transparency, and fostering a strong quality mindset. This role has significant impact on establishing and continuously improving local governance and oversight of quality records and processes. We support a mindset where we actively contribute to solving challenges, think new, and “create the job” by shaping and maturing the Review Board framework in close collaboration with operations.

About the Department/Team

You will be part of the BPO & Quality Support team in the Quality Assurance Support area, which supports the Hillerød site across a broad range of quality processes. The team consists of Business Process Owners (BPOs) for several major cross-functional quality processes such as CAPA/Deviations/Complaints, Change Management, Quality Risk Management, and APQR, and is responsible for frequent trending. This collaborative group brings together distinct expertise to ensure comprehensive quality management and processes. We work as quality partners for operations - understanding day-to-day challenges, facilitating shared solutions, and being part of the solutions, to create overview, strengthen governance, and support a quality mindset across the site.

Job Responsibilities

Your primary tasks:

• Establish, mature and maintain site governance for site Quality Review Boards and ensure continuous improvement is identified and implemented.
• Ensure and independently facilitate site Quality Review Boards that create value for operations by providing guidance, solving issues together, creating overview, and supporting a quality mindset.
• Proactively shaping the site Review Board structure, processes, and ways of working in partnership with operations and stakeholders.
• Drive a “think new” approach - innovate, simplify, and improve how we govern, report, and act on quality signals.
• Facilitate training in the site Quality Review Board process and governance principles.
• Facilitate meetings with stakeholders and identify improvements for the site Quality Review Boards.
• Present the site Quality Review Board process during audits and inspections.
• Present status and insights at the Quarterly Management Review (QMR).
• Ensure that our site Quality Review Boards supports customer expectations.
• Be an active part of the global network of site Quality Review Board managers across FDB sites

Qualifications

We are looking for a candidate with the following background and skill sets:

Professional qualifications:

• University degree in Natural Sciences, e.g., Pharmacy or similar.
• +7 years of experience with implementation of or working with governance boards and cross-functional forums.
• +7 years of proven practical experience with GMP quality systems and legislation.
• Proven quality experience and strategic understanding of business perspective.
• Proven experience of working with governance and Stakeholder Management.
• Proven AI experience (e.g., leveraging data/AI tools to drive insight, governance, or process improvements).
• High and strong Quality mindset and a track record as a quality partner for operations.

Personal qualifications

• Confident, independent, and professionally grounded.
• Persistent and disciplined; a strong driver who takes ownership.
• Pragmatic and improvement-minded with a “think new” approach.
• Ready for changes and challenges; thrives in a dynamic environment.
• Proactive, data-driven, and able to work independently.
• Enjoys working with multiple stakeholders in a large organization.
• Supportive and service-minded; focused on facilitating common solutions and being part of the solution.

Application

Has this sparked your interest? Then we urge you to upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis. Should you have any questions, please feel free to reach out to Manager Helene Lyngby Nielsen (helenelyngby.nielsen@fujifilm.com). Interviews will be conducted on an ongoing basis. Please expect some delay due to summer vacation.

FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark; Teesside, United Kingdom; RTP, North Carolina; Holly Springs, North Carolina; and College Station, Texas. 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 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 and hybrid working. Our facility also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.

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.