QCPD Specialist

About the role

Alvotech is seeking a QA professional to support combination product and device R&D and Design Control activities. The role ensures compliance with 21 CFR Part 820 and ISO 13485 throughout the product development lifecycle.

Key responsibilities

• Review and approve quality documentation (DHF, risk management files, etc.) generated by CPD R&D.
• Collaborate with R&D teams to provide quality guidance and coach on procedures.
• Author, review, and maintain quality procedures and supporting documents.
• Lead cross‑functional quality projects and support regulatory inspections.

Required profile

• Bachelor’s or Master’s degree in chemistry, biochemistry, biotechnology or equivalent.
• 5‑10 years of QA experience supporting devices or combination products.
• Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience with regulatory audits (FDA, EMA) and GxP requirements.

Required skills

• ISO 13485 compliance
• FDA 21 CFR Part 820 knowledge
• CAPA, change control, investigations, document management processes
• Physical device testing and characterization methods
• Veeva Quality system (preferred)