Quality Assurance Manager (GCP/GMP)

About the role

An innovative biotechnology company developing advanced therapies is seeking an experienced Quality Assurance Manager to ensure quality and regulatory compliance across clinical development (GCP) and manufacturing operations (GMP). The role will serve as the primary quality partner for Clinical Development and CMC teams, overseeing outsourced activities and supporting inspection readiness.

Key responsibilities

• Provide GMP quality oversight for outsourced manufacturing, reviewing deviations, OOS/OOT investigations, and QC activities.
• Track and close CAPAs and Change Controls, and review batch records, analytical documentation, specifications, validation documents, and sampling plans.
• Maintain and manage Quality Technical Agreements with manufacturing partners.
• Ensure GCP compliance by reviewing clinical documents (protocols, IBs, ICFs, DSURs) and monitoring TMFs and Sponsor Study Files.
• Coordinate GCP audits of sites, CROs, and vendors, and monitor vendor performance throughout studies.
• Support risk management, quality risk assessments, and product quality evaluations for both clinical and manufacturing phases.
• Contribute to the implementation, maintenance, and continuous improvement of the Quality Management System and audit/inspection readiness activities.

Required profile

• Minimum 10 years of Quality Assurance experience in biotechnology or pharmaceutical industry.
• Strong knowledge of both GCP and GMP regulations.
• Experience managing GxP vendors such as CROs and CMOs.
• Advanced degree (MSc, Engineering, PharmD or equivalent).

Required skills

• GCP
• GMP
• CAPA management
• Change Control
• Quality Management System
• Audit readiness
• Risk assessment