Program Quality Manager

FUJIFILM Biotechnologies; Hillerød; Hybrid; DKK 900,000 - 1,150,000; Full time

Benefits offered by this job

Health insurance

Massage and physiotherapy

Health check

Fitness center

Hybrid working

Canteen with Friday brunch

Job summary

FUJIFILM Biotechnologies seeks a senior Quality Assurance professional to join the Program Quality Management (PQM) team. The role acts as the pivotal link between customers and the FLBD team, managing quality topics across Drug Substance, Drug Product, and Finished Goods programs with independence and professional judgment.

You will handle commercial and Tech Transfer quality topics, drive discussions on deviations, changes, CAPAs, and customer communications, while promoting collaboration

Qualifications

• Master's degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with knowledge of GMP and quality systems and at least 10 years of QA experience.
• Experience operating between internal processes and external customers.
• Fluency in English is required as English is corporate language.

Responsibilities

• Be the primary QA contact to customers during commercial and Tech Transfer processes.
• Drive discussions with customers on deviations, changes, CAPAs, complaints.
• Prepare communications with customers on specific quality topics.
• Support revision of Quality Agreements and QA representation in the program core team.
• Participate in customer visits and audits; develop department documents and SOPs.

Skills

QA execution

Stakeholder management

Communication

Quality systems

Education

Master's degree in Biochemistry/ Biology/ Biotechnology/ Pharmaceutical Sciences

Job description

Aug 27, 2026

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 strongcollaboration 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.

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.