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 (PQM) at FUJIFILM Biotechnologies!

This role is suited for a senior QA professional with strong experience navigating complex quality topics.

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 FLBD team and expected to operate with a high level of independence and professional judgment in a complex stakeholder landscape

You will be involved in all quality related topics related to both Commercial and Tech Transfer programs making sure customers are informed and involved in the quality work related to their program. 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 to ensure the strong  collaboration between FUJIFILM operational 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

• The candidate holds a Master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with interest and knowledge of GMP and quality systems with a minimum of 10-year relevant QA experience.
• The perfect candidate has experience operating in the field between internal processes/organization and facing the collaboration with the external customers.
• You are service minded with excellent verbal and oral communication skills. Fluency in English is required as English is our corporate language.

This role demands 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

• Positive and organized with an attention to detail and still able to keep an overview in a changing environment.
• Your mindset is team oriented and collaborative

Your New Team & Department

The Program Quality Management (MFG) team consists of 9 highly skilled and dedicated team members with broad experience within pharmaceutical manufacturing. The team is an organization embedded in the Quality Assurance organization with links to a global PQM group 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 cas you have any questions, please do not hesitate to contact Head of Program Quality Management, Manufacturing, Annelise Olsen +45 41945471

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.