Customer Program Quality Manager

Are you an experienced Quality Assurance professional with a passion for collaborating with biopharma companies and ensuring cutting-edge quality in Drug Substance, Drug Product, and Finished Goods manufacturing?

Do you thrive in dynamic settings where you can be the pivotal link between customers and your team, driving discussions and ensuring seamless communication on all quality-related topics?

Then we hope you will join the Program Quality Management team for Manufacturing (PQM MFG)!

Your New Role

We work with various biopharma companies, which means each project we work on brings a unique set of tasks. You will be the link between our customers and our FDB team.

You will be involved in all quality related topics related to the Tech Transfer 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.

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.

Main Responsibilities

• Be the primary point of contact to customers regarding quality related topics both during commercial and Tech Transfer processes
• Drive discussions with customers to support ongoing activities for example on deviations, changes, CAPAs, complaints
• Be a link between customer and internal organization; preparing upcoming communication with customers on specific quality topics
• Support revision of existing Quality Agreements
• Support manufacturing activities including representing quality assurance in the core team for the program
• Prepare and participate in customer visits and audits
• Establish, develop and maintain department documents: customer presentations, SOPs and participate in our internal Continuous Improvement activities
• Ad hoc tasks
  
  
  

Skills & Knowledge, We Hope You Possess

• A masters degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with interest and knowledge of GMP and quality systems
• A minimum of 5-10-year relevant QA experience.
• Fluency in English is required as English is our corporate language.
• This role requires that you facilitate operational elements in the actual program execution. It requires a personality that induce sufficient business acumen and process insight to drive, facilitate, and manage stakeholders across the entire business with authority and charisma.
  
  
  

We hope you are

a positive and organized team player with a keen eye for detail and a natural ability for keeping the overview in a dynamic environment.

Your New Team & Department

The Program Quality Management (MFG) team consists of 10 highly skilled and dedicated team members with broad experience within pharmaceutical manufacturing. The team is an organization embedded in the Quality organization under Program Quality and provides quality support to production of engineering, clinical, PPQ and commercial batches in large scale Drug Substance manufacturing, filling of Drug Product and Assembly, Label and Pack.

The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Your application

Does this sound interesting? Then please upload your CV and cover letter as soon as possible, as we will continuously invite relevant candidates for job interviews. The job advertisement will be removed when the right candidate has been identified.

In case you have any questions, please do not hesitate to contact Head of Program Quality Management, Manufacturing, Annelise Olsen +45 41945471

FUJIFILM Diosynth Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.

Our success starts with our people — their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.

Shape the future with us — your drive meets boundless opportunity here https://fujifilmdiosynth.com/

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.