Senior QA Associate, Materials, Supply Chain & Warehouse

FUJIFILM Biotechnologies; Hillerød; On-site; DKK 650,000 - 850,000; Full time

Job summary

FUJIFILM Biotechnologies in Hillerød, Denmark is seeking a Senior QA Associate to provide quality oversight for Materials, Supply Chain, and Warehouse operations, with a focus on material qualification and 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.

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.
• Proven understanding of biologics manufacturing and Quality Control complexity.
• Strong GMP quality systems knowledge incl. 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.

Responsibilities

• 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.

Skills

QA leadership

GMP knowledge

Documentation

Cross-functional

Risk management

Audits & inspections

Materials qualification

ERP/LIMS

Regulatory compliance

Quality systems

Education

Science degree (Chemistry/Biology/Pharma)

Tools

ERP/LIMS

eQMS

CAPA tools

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.