Are you a QA Manager, who loves building innovative systems, looking for a move into technology? We've got a great Risk Based Quality Management Implementation Consultant (Data Manager) role. This is a remote position but our client's offices are in Cambridge.

We are looking for a dynamic and motivated QA Manager who will report directly to the CEO and work closely in partnership with the Operations, Finance and Technology functions. We need someone with the experience to run the QA function without handholding, but who is also able to work

collaboratively with functional leads as and when needed.

The three main pillars of the role are as follows:

1. Ongoing management and improvement of existing QMS

2. Supporting readiness for ISO 27001 and latterly the ongoing maintenance and periodic re-certification

3. Managing internal and external audits

The QA manager will ideally have experience of working for a clinical technology led business and understand the demands on QA from a GCP and ISMS perspective.

Characteristics

• Minimum of five years of relevant experience
• Self-motivated and willing to take ownership and accountability
• Able to work alone but to collaborate and communicate effectively with peers from the leadership and management teams as needed
• Good understanding of GCP and information security management in a Software as a Service (SaaS) environment

The key functions performed by the QA Manager will include, but may not be limited to the following areas:

• Management and oversight of the Quality Management System and associated documents
• Plan and deliver internal audit schedule
• Support Through completion of the ISO 27001 certification program and ongoing maintenance and re-certification
• Agree with Senior Leadership Team (SLT) and report on Quality metrics for the organization
• Coordinate and contribute to client audits
• Coordinate and contribute to regulatory inspections
• Specify quality and regulatory requirements relating to suppliers
• Coordinate vendor qualification and oversight
• Advise and consult the SLT, Product Development and Operations personnel on regulatory requirements
• Be aware of, and share information regarding, evolving regulatory requirements
• Formally review business processes and outsourced functions with regard to regulatory compliance
• Determine, recommend and review in-house quality procedures, standards and specifications
• Management and oversight of Corrective and Preventative Action (CAPA) process Act as a regulatory advisor on Computer System Validation and compliance (CSV&C) and GCPspecifically, and applicable regulations generally
• Act as QA reviewer on TRI product validation and change controls
• Assess customer quality requirements and ensure that they are met
• Ensure that company processes comply with standards at both national and international level
• Work with operational staff to establish processes, procedures, systems and standards
• Direct objectives to optimise product and service quality
• Work with management to determine functional training needs

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