Experienced Business Process Owner for Quality Risk Management

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 Business Process Owner (BPO) for Quality Risk Management (QRM) who shares our passion, drive, and energy – what we call Genki – to build strong QRM competences across the Site and consolidate a compliant and agile program for QRM in collaboration with our Global network.

The position

You will take on the role as BPO for QRM for the entire Hillerød site in Denmark. The position is anchored in Quality, but your ability to work, understand and connect with all departments is key to being a success in this role. The role holds great impact to continuous implementation and improvement of the local and global management of quality risks.

About the Department/Team

You will be part of BPO & Quality Support team in Quality Assurance Support area, which is supporting the Hillerød site on a broad variety of different quality processes. The BPO & Quality Support consists of BPOs for several major quality processes used cross functional like CAPA/Deviations/Complaints, Change Management and APQR, and are at the same time responsible of Quality Review Boards, the Quality Management Review process and frequent trending. This collaborative group brings together distinct expertise to ensure comprehensive quality management and processes. We aim to foster a collaborative environment, where diverse perspectives and people come together united by a common purpose and shared values.

Job Responsibilities

Your primary tasks:

• Establish, mature and maintain a robust governance structure for Quality Risk Management
• Have oversight over the Quality Risk Management Process
• Facilitate larger Quality Risk workshops
• Facilitate training in the Quality Risk Management Process (local + global)
• Facilitate meetings with the core team and identify improvements for Quality Risk Management
• Present the area and process during audits and inspections
• Present status at the Quarterly Management Review
• Ensure that our Quality Risk Management system supports customer requirements and improvements are identified and implemented
• Be an active part of the global network of local BPOs for Quality Risk Management 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 working strategic with Quality Risk Management – strategy, process and tools.
• +7 years of proven practical experience with GMP quality systems and legislation.
• Proven experience of working with governance and Stakeholder Management.
• Proven quality experience and strategic understanding of business perspective.
• 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.
• Thrive in a changing environment

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.