Senior QA Associate, Materials, Supply Chain & Warehouse

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 &…