Senior QA Lead - Materials & Supply Chain (GMP)

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

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.