Our client is one of the largest specialist data focused contract research companies in Europe supporting human clinical trials developing new life saving drugs. Using its innovative Electronic Data Collection system, ePRO mobile app and related biometrics services, market leader in the healthcare arena. The Norfolk based specialist clinical biometrics CRO is supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services.
We are looking for an individual with in depth knowledge and experience in good clinical practice in the pharmaceutical industry, with excellent interpersonal and communications skills and that 'can-do' attitude who is interested in joining as the Quality Assurance Manager, with the opportunity for the individual to grow and develop further within our expanding organisation.
You will be responsible for the management of the quality system processes and procedures, the Quality Assurance team as well as the management of the quality system design, controls and continuous improvement programme.
Responsibilities of the Role:
Management of the quality system processes and procedures and the Quality Assurance team
Management of departmental objectives and budget
Manage a risk based internal audit system and continually review and develop appropriate metrics for QA annual Trend Analysis including tracking and trending of CAPAs
Manage the risk-based service provider audit programme and perform key service provider audits as required
Plan, co-ordinate and follow-up on the internal and external audits undertaken by the auditing team
Manage and host regulatory authority inspections and sponsor audits by the Quality Assurance team
Manage the QA team workloads
Undertake team appraisals
Provide operational staff with expert advice and support in relation to good quality practice regulations and guidelines and process knowledge
Develop, organise and provide quality management and regulatory training for all staff, consultants and where required Sponsors
Responsible for the management of the company Clinical eQMS (Q-Pulse) system
Deputises for the archivist as required
Management of the quality system design, controls and continuous improvement programme
Lead, develop and execute company strategy and operating structure for all quality and regulatory matters in relation to the principles of Good Clinical Practice
With the help of the senior management team drive quality and compliance infrastructure development to ensure appropriate policies, procedures and best practices are in place
With the help of the senior management team deliver a multi-year strategy within quality management to ensure competitive advantage and continuous improvement
Facilitate business relationships with internal stakeholders at all levels
Partner with colleagues to proactively identify and mitigate risks
Manage and provide Quality Assurance consultancy as required
The role can be either home-based or on site-based
- Quality Assurance
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