Quality Assurance QMS Manager

Senior Manager, QMS & GMP Global Quality Assurance

Our client are seeking a (Senior) Manager, GMP QA to join its dynamic Quality Assurance team. This role is essential for maintaining and improving the company’s Quality Management System (QMS) and ensuring compliance with Good Manufacturing Practice (GMP) standards.

Key Responsibilities

• Enhance and implement the company’s QMS to align with GMP principles.
• Prepare and review Standard Operating Procedures (SOPs) for QA GMP and related systems.
• Maintain Product Specification Files.
• Assess quality events, including deviations, root cause investigations, CAPA, and OOS.
• Support Quality Risk Management activities for Medicinal and Investigational Medicinal Products.
• Oversee QA-related activities in change management processes.
• Generate quality reports and key performance metrics.
• Prepare and facilitate Quality Management Reviews.
• Host regulatory GMP inspections and audits.
• Supervise GMP/GDP training programs.

Key Competencies

• Strong background in Quality Assurance and GMP compliance.
• Proficiency in QA systems and processes.
• Experience with training and compliance with Part 11 regulations.

Start Date: ASAP

This is a fantastic opportunity to contribute to a high-growth environment and play a key role in maintaining the highest quality standards.