Quality Assurance Manager

We are seeking an experienced and motivated Quality Assurance Manager to join our Quality Assurance team. This role is responsible for maintaining and enhancing the Quality Management System (QMS), ensuring compliance with global regulatory requirements, and driving continuous quality improvement across the organization.

The successful candidate will lead internal and external audit activities, support regulatory inspections, oversee quality systems and documentation, and collaborate with stakeholders across the business to promote a culture of quality and compliance.

What You'll do?

• Maintain and continuously improve the Quality Management System (QMS).
• Provide guidance and consultation to staff on quality and regulatory compliance matters.
• Plan, manage, conduct, and report internal audits, vendor audits, and GPvP audits.
• Facilitate regulatory inspections and accreditation audits.
• Manage customer audits, including pre-study and active study audits.
• Oversee the review, update, and maintenance of Standard Operating Procedures (SOPs).
• Monitor and communicate changes in local and global regulations relating to clinical research and quality activities.
• Maintain and manage the Corrective and Preventive Action (CAPA) system and database.
• Lead continuous improvement initiatives arising from audit findings, inspections, and quality reviews.</