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.
• Host and support ISO accreditation audits.
• Support quality-related activities, including Computer System Validation (CSV), vendor management, training, and quality reviews.
• Collaborate with cross-functional teams and subject matter experts to ensure compliance and quality excellence.
• Provide leadership, coaching, and support to Quality Assurance team members.
• Perform additional Quality Assurance responsibilities as assigned by the Head of Quality Assurance.

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.