QA Manager (Senior) – GxP Quality Assurance

About the role

AviadoBio is developing gene therapies for neurodegenerative disorders and seeks an experienced QA Manager to lead quality systems in a fast‑paced, GxP‑regulated environment. The role sits within the Quality Assurance team and works closely with Manufacturing, R&D, Regulatory Affairs and Supply Chain.

Key responsibilities

• Maintain and continuously improve the Quality Management System (QMS) in line with GxP and ICH guidelines.
• Oversee SOP creation, review, release and version control.
• Lead Event, Change Control, CAPA and Deviation processes from initiation to closure.
• Provide quality oversight for manufacturing, supply chain, non‑clinical and clinical activities.
• Manage the electronic QMS (eQMS) and ensure all records are up to date.
• Plan and conduct internal and vendor GxP audits, track findings and ensure timely CAPA closure.
• Support supplier qualification programmes and review supplier quality agreements.
• Design and deliver QA training, maintain SOP training matrix and ensure GxP training compliance.

Required profile

• Degree (or equivalent) in Life Sciences, Chemistry, Pharmacy or related field.
• Extensive QA experience in a GxP‑regulated industry (pharma, biotech, medical devices or CDMO).
• Proven experience managing regulatory authority inspections.
• Strong working knowledge of GMP, GCP and relevant ICH guidelines.
• Experience managing eQMS processes and supplier quality programmes.

Required skills

• eQMS management
• GMP compliance
• GxP regulations
• ICH guideline application
• CAPA management
• Change Control
• Audit execution
• Supplier qualification