Senior QA Lead: Materials & GMP Onboarding

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; Hybrid; DKK 700,000 - 1,000,000; Full time

Benefits offered by this job

Hybrid working

Health insurance

Fitness center

Job summary

FUJIFILM Biotechnologies in Hillerød, Denmark is seeking a Senior QA Associate to oversee materials, supply chain and warehouse quality activities. The role centers on material qualification and onboarding for GMP manufacturing, aligning with cGMP and internal procedures.

You will train and guide stakeholders, perform quality walks, and drive cross‑functional improvements while staying current with regulatory expectations and quality systems. Hybrid work and a collaborative culture are offered.

Qualifications

• Bachelor’s or Master degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences or related field with 7+ years in pharma/biotech QA.
• Deep understanding of biologics manufacturing and QC complexity.
• Strong knowledge of GMP quality systems including change control, deviations, CAPA, and documentation control.
• Experience with material qualification and onboarding of new materials for GMP manufacturing.
• Familiarity with excipients, regulatory considerations and supplier qualification.
• Proven risk management experience and cross-functional improvement initiatives.
• Experience with audits/inspections and ERP/MES/LIMS or quality systems is a plus.

Responsibilities

• Lead QA material qualification and onboarding for GMP use by assessing documentation and records.
• Provide QA support to materials, supply chain, and related activities, ensuring cGMP alignment.
• Develop and maintain compliant documentation; train stakeholders across departments.
• Conduct quality walks and gemba walks; document observations and follow‑ups.
• Participate in cross‑functional projects to implement process improvements.
• Support audits/inspections and contribute to readiness and response activities.

Skills

QA

GMP

Material qualification

Documentation control

CAPA

Change control

Risk management

Audits/inspections

ERP/MES/LIMS

eQMS

Education

Bachelor’s or Master in Chemistry/Biology/Biochemistry/Pharmaceutical Sciences +7 years

Tools

ERP/MES/LIMS

eQMS

Job description

FUJIFILM Biotechnologies in Hillerød, Denmark is seeking a Senior QA Associate to oversee materials, supply chain and warehouse quality activities. The role centers on material qualification and onboarding for GMP manufacturing, aligning with cGMP and internal procedures.

You will train and guide stakeholders, perform quality walks, and drive cross‑functional improvements while staying current with regulatory expectations and quality systems. Hybrid work and a collaborative culture are offered.