Senior QA Associate (Pharmaceutical, Hillerød)

Job summary

Seeking a Senior QA Associate to oversee quality for Materials, Supply Chain, and Warehouse operations, focusing on material qualification and onboarding for GMP manufacturing. This role involves leading quality activities, acting as a partner to Operations, and driving continuous improvement at the site in Hillerød, Denmark.

Qualifications

• Bachelor's or Master's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related field
• Over 7 years of experience in the pharmaceutical or biotech industry, particularly in Quality Assurance
• In-depth knowledge of biologics manufacturing and Quality Control complexities
• Strong understanding of GMP quality systems, including change control, deviations, CAPA, and documentation control
• Advanced expertise in material qualification and onboarding for GMP manufacturing
• Familiarity with excipients and supplier qualification
• Experience in risk management, audits, and cross-functional improvement initiatives
• Proficiency with ERP/MES/LIMS and quality systems (e.g., eQMS) is advantageous

Responsibilities

• Lead QA material qualification and onboarding for GMP use by reviewing documentation and records
• Provide QA support to ensure compliance with cGMP and internal procedures
• Ensure adherence to procedures and capture compliant documentation
• Act as a quality partner, offering guidance and training to stakeholders across various departments
• Conduct quality and gemba walks, documenting findings and follow-ups
• Participate in cross-functional projects to implement process improvements
• Support audits and inspections, contributing to readiness and response activities

Skills

• Strong risk-based decision-making abilities
• Excellent documentation practices and attention to detail
• Effective communication and collaboration skills
• Continuous improvement mindset, identifying and sharing best practices

Education

• Bachelor's or Master's degree in a relevant field

Tools

• Familiarity with ERP, MES, LIMS, and quality management systems