Senior Biopharma Program Quality Lead

FujiFilm; Hillerød; Hybrid; DKK 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Hybrid working

Canteen on site

Fitness center

Job summary

FUJIFILM Biotechnologies in Denmark seeks an experienced Senior QA professional to bridge customers and the FLBD team on quality topics for Drug Substance, Drug Product, and Finished Goods manufacturing.

You will drive quality discussions during commercial and Tech Transfer, support quality agreements, and participate in audits, with a global, high-paced team focused on integrity and impact.

Qualifications

• Master’s degree with knowledge of GMP and quality systems.
• Minimum 10 years of QA experience in biopharma or related field.
• Experience coordinating between internal processes and external customers.
• Fluent in English with strong verbal and written communication.

Responsibilities

• Be the primary contact to customers on quality topics during commercial and Tech Transfer.
• Drive discussions on deviations, changes, CAPAs and complaints with customers.
• Link between customer and internal organization; prepare communications on quality topics.
• Support revision of existing Quality Agreements.
• Represent QA in the core program team for manufacturing activities.
• Prepare and participate in customer visits and audits.
• Develop and maintain department documents: SOPs and CI activities.

Skills

Stakeholder management

Verbal communication

Written communication

GMP knowledge

English language

Education

Master’s degree in Biochemistry, Biology, Biotechnology, or Pharmaceutical Sciences

Tools

GMP systems

Job description

FUJIFILM Biotechnologies in Denmark seeks an experienced Senior QA professional to bridge customers and the FLBD team on quality topics for Drug Substance, Drug Product, and Finished Goods manufacturing.

You will drive quality discussions during commercial and Tech Transfer, support quality agreements, and participate in audits, with a global, high-paced team focused on integrity and impact.