About the Role

Part-time (60-80%) Senior QA Auditor to lead QA activities across clinical research (GCP) and manufacturing (GMP), ensuring compliance with SOPs and regulations and managing the Quality Management System (QMS).

Key Responsibilities

• Manage QMS, SOPs, change control, deviations and CAPAs.
• Conduct internal and external audits and oversee third-party auditors and vendor qualification.
• Review batch records, investigate OOS results and perform root cause analysis.
• Coordinate with Regulatory Affairs for submissions and inspections (MHRA, FDA, EMA).

Requirements

• At least 7 years' experience in pharma/biotech/CRO with Clinical Operations and QA exposure.
• Bachelor's degree in a life science or related field.
• Deep knowledge of ICH-GCP and GMP regulations.
• Strong analytical, communication and stakeholder management skills.