Business Process Owner for Change 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.

About the Role
You will take on a role as a Business Process Owner (BPO) for Change Control Management for the entire site. The position is anchored in Quality, but your ability to understand and connect with all departments are key to being a success in this role. This role is related to how we process Change Controls and how they are documented in FDB’s system.

About the Department/Team
You will report into our Quality System & Support function, which is one of our centralized QA departments. Today this area consists of 4 teams, and in addition also the BPO for CAPA and Deviation management.

Job Responsibilities
Your primary tasks:

• Have oversight with the Change Control Management Process
• Facilitate training in the Change Control Management Process (today both local + global training)
• Facilitate meetings with the superuser team and identify improvements for Change Control Management
• Present the area during audits and inspections
• Present status at the Quarterly Management Review
• Ensure that our Change Control Management system supports customer requirements and improvements are identified and implemented
• Ensure alignment 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
• Knowledge of GMP quality systems and legislation
• High-Quality mindset
• Understanding of business perspective
• Stakeholder Management

Personal qualifications

• Serviceminded
• Proactive in your approach
• Able to work independently
• Datadriven
• Thrive in a changing environment
• Enjoy working with multiple stakeholders in a large organization

Application
Has this sparked your interest? Then we urge you to please 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 our recruitment partner, Marlene Jansen at [email protected]

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.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, 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

Location: FDBD Hillerod