Senior QA Associate, Materials, Supply Chain & Warehouse

FUJIFILM Biotechnologies; Hillerød; On-site; DKK 700,000 - 900,000; Full time

Benefits offered by this job

Health insurance

Massage & physiotherapy

Health checks

Fitness center

Hybrid working

Canteen with Friday brunch and cake

Bell ringing tradition

Job summary

FUJIFILM Biotechnologies in Denmark is seeking a Senior QA Associate to provide quality oversight for Materials, Supply Chain, and Warehouse operations, with a primary focus on material qualification and onboarding for GMP manufacturing. You will own complex, cross-functional quality activities and partner with Operations to drive continuous improvement.

Qualifications include a Bachelor’s or Master in a relevant field and 7+ years in pharma/biotech QA, with deep GMP knowledge and experience

Qualifications

• Bachelor's or Master in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences or related field.
• +7 years in pharma/biotech, preferably QA.
• Strong GMP quality systems knowledge: change control, deviations, CAPA, documentation control.
• Advanced material qualification and onboarding for GMP manufacturing experience.
• Familiar with excipients, regulatory considerations and supplier qualification.
• Strong risk management experience.
• Experience supporting audits/inspections and cross-functional improvements.
• Experience with ERP/MES/LIMS and quality systems is a plus.

Responsibilities

• Lead QA material qualification and onboarding for GMP use.
• Provide QA support to materials and supply chain per cGMP procedures.
• Ensure procedures and documentation are complete and compliant.
• Train and mentor Stakeholders across Operations, QA, QC, Warehouse and Supply Chain.
• Maintain training compliance and stay current on cGMPs and regulatory expectations.
• Conduct quality walks and gemba walks with stakeholders and document findings.
• Participate in cross-functional projects to identify and implement process improvements.
• Support audits and inspections by authorities and external parties.

Skills

GMP knowledge

Quality systems

Change control

Deviations & CAPA

Documentation practices

Risk management

Audits & inspections

Cross-functional collaboration

Training & mentoring

Gemba walks

Education

Bachelor’s or Master in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

ERP/MES/LIMS

eQMS

Job description

We are seeking a Senior QA Associate to provide quality oversight for Materials, Supply Chain, and Warehouse operations, with a primary focus on material qualification and new material onboarding for GMP manufacturing. You’ll own complex, cross-functional quality activities, act as a trusted partner to Operations, and drive continuous improvement across systems and processes at our site in Hillerød, Denmark.

What You’ll Do

• Lead QA material qualification and new material onboarding for GMP use by assessing and approving documentation and records (e.g., changes, deviations, CAPAs)
• Provide QA support to materials and supply chain activities, ensuring alignment to cGMP and internal procedures
• Ensure procedures and methodologies are followed; capture and report complete, compliant documentation
• Act as a quality partner providing guidance, training, and ad hoc support to stakeholders across Operations, QA, QC, Warehouse, and Supply Chain
• Maintain personal training compliance; stay current on cGMPs, regulatory expectations, and global procedures, policies, and specifications
• Conduct quality walks and gemba walks with stakeholder departments, documenting observations and follow-ups
• Participate in and/or lead cross-functional projects and working groups to identify and implement process improvements for Quality and partner functions
• Support audits and inspections by authorities and external parties; contribute to readiness, hosting, and response activities

Qualifications

• Bachelor’s or Master degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences or other relevant academic education
• +7 years of experience in the pharmaceutical/biotech industry, preferably in Quality Assurance
• Profound understanding of biologics manufacturing and Quality Control complexity
• Strong working knowledge of GMP quality systems, including change control, deviations, CAPA, and documentation control
• Advanced knowledge of material qualification and onboarding of new materials for GMP manufacturing
• Familiarity with excipients, including regulatory considerations and supplier qualification
• Strong risk management experience (risk assessment, mitigation, and control)
• Experience supporting audits/inspections and cross-functional improvement initiatives
• Experience with ERP/MES/LIMS and quality systems (e.g., eQMS) is a plus
• Deep QA subject‑matter expertise in GMPs; capable of independently executing complex, cross‑functional tasks
• Proven ability to challenge the status quo and implement practical, value‑adding process improvements
• Strong risk-based decision‑making; balances performance, compliance, and patient safety
• Excellent documentation practices and attention to detail; ensures completeness and data integrity
• Effective cross‑functional collaborator; clear, concise communicator and trainer/mentor to peers
• Continuous improvement mindset; identifies and scales "bright spots," shares best practices, and builds team capability

Your New Team & Department

You will be a part of the Quality Assurance for Quality Control & Supply Chain department, which ensures quality oversight over Quality Control and Supply Chain. In our team Quality Assurance for Materials & Supply Chain, we focus on ensuring quality oversight over incoming materials, logistics and warehouse activities. We aim to foster a collaborative environment, where diverse perspectives and people come together united by a common purpose and shared values.

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.