Senior QA Associate, Materials, Supply Chain & Warehouse

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 750,000 - 1,050,000; Full time

Benefits offered by this job

Health insurance

Hybrid working

Canteen & Friday brunch

Job summary

FUJIFILM Biotechnologies in Hillerød, Denmark, seeks 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 will own complex QA activities, partner with Operations, QA, QC, and Supply Chain, and drive improvements across systems and procedures while maintaining cGMP compliance and robust documentation practices.

Qualifications

• Bachelor’s or Master degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences or related field with 7+ years in pharma/biotech QA.
• Deep knowledge of GMP quality systems and documentation control.
• Strong understanding of material qualification and onboarding for GMP manufacturing.

Responsibilities

• Lead QA material qualification and new material onboarding for GMP use; assess and approve changes, deviations, CAPAs.
• Provide QA support to materials, supply chain, and related activities with cGMP alignment.
• Conduct gemba walks and document observations; lead cross-functional improvement initiatives.

Skills

Cross-functional collaboration

Training & mentoring

Documentation practices

Quality mindset

Process improvement

Risk management

Education

Bachelor’s or Master degree in Chemistry/Biology/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.

We are part of the Fujifilm Group, and we all share the same purpose. Giving our world more smiles. We bring diverse ideas, unique capabilities, and extraordinary people together to change the world. FUJIFILM Biotechnologies works in strategic collaboration with biopharmaceutical and biotech companies to develop and manufacture the latest in biologics, advanced therapies and vaccines. With production facilities in the US and Europe, we give our customers everything they need to develop and commercialize treatments and therapies effectively and efficiently to make patients’ lives better.

We are driven to revolutionize the industry through our Partners for Life mindset, seeking to build global partnerships based on trust with our customers. Our global teams fully embrace our aspiration of being the leading and most trusted Partners for Life in the biopharmaceutical industry.