Quality Systems Manager

We are looking for an Industry leading Quality Systems Manager, ideally office based in Cambridge,(Flex can be discussed ) who wants to apply knowledge and experience to the creation of a leading edge web application for the clinical trials industry.

Our client is growing at pace due to the success of their Industry leading products and are leading global providers of Risk-Based Monitoring (RBM) solutions for clinical trials, in order to expand its international presence and to keep up with the demand they need to grow their team that's where you come in!

Their mission is to improve clinical trial outcomes through intelligent application of technology.

So if you are a self-motivated individual who would enjoy working on a small, results oriented team where your input is valued, Read on.

Here's a snap shot of what you will be doing:

The QMS Manager is responsible for supporting a robust Quality Management System and will ensure that continuous improvement initiatives are championed.

• As the Quality Systems Manager you will be responsible for ensuring that all software and infrastructure provided to customers in a GxP impacted environment is maintained in a verified state in accordance with the requirements of the applicable rules, regulations and guidelines, and industry standards, such as

GAMP 5, ICH GCP E6 R2, CFR 21 part 11, ISO9001, HIPAA.

• Will work with the teams where necessary to ensure that the operating company is maintained in a position of being ready for customer audits and agency inspections
• The QMS Manager will be involved with the routine activities associated with the requirements of the General Data Protection Regulations (GDPR) Responsibilities

Personal: To maintain training records for self.

• Quality Management System (QMS) - to follow, review and assist in the improvement of the QMS in the quality function for, ensuring that the following activities are carried out:
• To assist in the implementation and maintenance of policies and procedures to control the validation of software applications (and the qualification of hardware infrastructure with our providers) in a software development environment.

QA Operations - to ensure that the following activities are carried out:

• Ensuring that processes needed for the Quality Management System (QMS) are established, implemented and maintained.
• Ensuring that the QMS, and associated documentation, meet all required internal and external Quality and Compliance standards.
• To ensure all System Testing/Verification/Validation is performed in accordance with International Guidance's.
• Approval of Quality documentation on behalf of the company
• Liaise with customers regarding quality/compliance topics as required
• Preparation and management of customer inspections and on-site audits, including all follow-up activities and remedial actions as necessary
• Ensure that appropriate assessments/audits of TRI suppliers and technology partners are undertaken and correctly documented
• Report to the CEO and work with the Quality team on the performance of the QMS and any need for improvement. Ensure improvements are fully assessed and implemented as necessary, following the agreed internal change management processes
• Providing appropriate guidance/mentoring to ensure all staff have an understanding of GxP and how the requirements should be applied within
• Partnering with the various departments to ensure that all aspects of their SaaS product meet the standards required by Life-Sciences organisations operating within a highly-regulated environment
• Acting as system manager/administrator on key company support systems (eQMS, Training, Document Control) ensuring their continued operation in accordance with appropriate regulations and customer requirements
• Preparation of key procedural documents, and provision of input to other staff, to ensure that they meet internal and client requirements. Ensure implementation of new or updated documentation follows a consistent path and that relevant staff receive training
• Ensuring that all Corrective and Preventative Actions (CAPAs) are documented and resolved in a timely manner Information Privacy and Security
• To ensure that documentation associated with information governance is current and accurate
• To create the internal audit plan for the software and conduct th