Senior QA Program Quality Manager

at  Fujifilm Diosynth Biotechnologies

Do you have QA experience? Are you interested in coordinating Quality information to our customers to keep them updated around the manufacturing of their products? Then you might be the person we are looking for!
Come and join our QA Program Quality Management Team at Fujifilm and play a key role in the relationship with our customers. With a fast-expanding site, our team is growing to support our increased number of customers.
The QA Program Quality Managers (QA PQMs) are accountable for the communication of all quality related topics affecting customer’s programs for production of Drug Substance, Drug Product and Finished goods. The communication is based on the responsibilities defined in Quality Agreement (QUAG).
About the Role
We work with a myriad of biopharma companies, which means each project we work on brings a unique set of challenges. As a QA PQM, you will be the link between our customers and our FDB team. You will have the opportunity to work and build relationships with customers as well as internal cross-functional teams.
Being the point of contact for our customers, our QA PQMs are great ambassadors. You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest amount of integrity and impact. The role also focuses on Quality Agreement and negotiations of these to ensure we have an accurate and effective approach to our cooperation. If you want a high-visibility, cross-discipline, intensely collaborative position with undeniable importance, apply today.
Job Responsibilities

Your primary tasks will be:

• Be the key link to customers regarding quality-related topics, for example, Deviations, Changes, Disposition of batches and various ad hoc requests
• Drive discussions with customers to establish new QUAGs, as well as continuous revision of QUAGs
• Support Technical Transfers/Process Performance Qualifications manufacturing activities
• Coordinate customer/cross-functional team meetings
• Prepare and participate in customer visits
• Work on projects to establish and improve processes for the team

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

Professional qualifications

• Master’s Degree (MSc) in natural Science, e.g. Pharmacy, Biotechnology or similar
• +5 years of experience with bio-pharmaceutical production is required
• Excellent communication skills and fluency in English
• QA experience
• Preferably experience with external stakeholder communication and project management/coordinator role

Personal qualifications
As a person, you approach tasks and colleagues with openness and great energy. You possess a structured mindset and understand the importance of involving stakeholders in your daily work. You are self-starter and have a flexible, dynamic approach to work.
If you see yourself as a great team player, positive mindset that enjoys a high paced environment with many interactions, then you might be just the candidate, we are looking for.
Your application
We will be conducting ongoing interviews, so please be sure to apply as soon as possible. We look forward to reading your resume!
About the Department/Team
QA PQM is a growing team of six highly skilled and dedicated team members with broad experience within pharmaceutical manufacturing. QA PQM is an organization embedded in the Quality organization which is a department that provides quality support to production of engineering, clinical, PPQ and commercial batches in large scale manufacturing, filling of drug product and Assembly, Label and Pack.
We are involved in all quality-related topics affecting customer’s programs and make sure customers are informed and involved to feel confidence in our collaboration. You will interact with highly skilled personnel to support your communication on complex activities. We continuously strive to identify opportunities to improve systems and practices and provide direction to our manufacturing group as well as technical development teams and our customers.
About FUJIFILM Diosynth Biotechnologies
Follow Your Genki to FUJIFILM Diosynth Biotechnologies
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.
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.
About Us
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.
Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
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.

• Be the key link to customers regarding quality-related topics, for example, Deviations, Changes, Disposition of batches and various ad hoc requests
• Drive discussions with customers to establish new QUAGs, as well as continuous revision of QUAGs
• Support Technical Transfers/Process Performance Qualifications manufacturing activities
• Coordinate customer/cross-functional team meetings
• Prepare and participate in customer visits
• Work on projects to establish and improve processes for the tea