Biopharma Program Quality Lead

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

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