R&D Quality Lead — GxP Compliance & CAPA

Sandoz; Cambourne; On-site; GBP 65,000 - 90,000; Full time

Job summary

Sandoz, based in the United Kingdom, is seeking a Quality Assurance professional to provide expertise and guidance to development and research activities, ensuring compliance with GxP and regulatory requirements. You will support health authority inspections, create Quality Plans for clinical programs, and drive initiatives to improve quality and compliance across projects.

You will assist with risk management, QA reporting, CAPA investigations and remediation, and ensure training needs are

Qualifications

• Quality assurance expertise in development and research organizations to ensure compliance with regulatory requirements and Novartis procedures and quality standards.
• Experience maintaining regulatory-required files for health authority inspections and assisting with inspection management.
• Ability to generate and review Quality Plans for clinical programs and ensure QA coverage across projects.
• Experience driving quality, process and compliance improvements, including CAPA identification and execution.
• Knowledge of GxP regulations and QA training needs identified from audits and assessments.

Responsibilities

• Support health authority inspection readiness and file maintenance.
• Assist in creating and reviewing Quality Plans for clinical programs.
• Contribute to quality performance initiatives including risk management and QA reporting.
• Identify opportunities for quality and compliance improvements and develop corrective actions.
• Lead or support CAPA investigations and monitor closure and documentation.
• Manage quality aspects of projects and third-party activities, including IT validations and instrument quality.

Skills

GxP quality

Regulatory inspection support

Quality systems

CAPA

Audit management

Risk management

Process improvement

Cross-functional collaboration

Job description

Sandoz, based in the United Kingdom, is seeking a Quality Assurance professional to provide expertise and guidance to development and research activities, ensuring compliance with GxP and regulatory requirements. You will support health authority inspections, create Quality Plans for clinical programs, and drive initiatives to improve quality and compliance across projects.

You will assist with risk management, QA reporting, CAPA investigations and remediation, and ensure training needs are