Global Senior Computerized Systems Strategy Lead

Recruiter
Roche
Location
Bedfordshire
Posted
10 Oct 2018
Closes
17 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Do you have strong Computerised System compliance knowledge, preferably in Clinical Trials, personalised medicine and/or Real World Data, as well as traditional validation that you can apply pragmatically? Just as importantly, are you a strategic and critical thinker, learning agile and truly want to work in a fast paced innovative environment with a team of great people striving to deliver existing and urgent new medicines to patients? If you are, you might be what I am looking for. Responsible for design and implementation of a risk based audit and quality assurance oversight for Computerised Systems, you’ll be involved in monitoring processes and project activities to identify risks and providing leadership to stakeholders on Computerized System Lifecycle issues. Supporting the wider business by assessing specific risk areas on an ongoing basis and delivering guidance to senior leadership on proposed modification to the wider PDQA strategy as appropriate, you’ll partner with other strategic partners to develop annual audit programs and risk assessments for Computerized Systems supporting PV, GCP and GLP processes. Assessing data and metrics from audit activities and inspections, you’ll identify compliance trends and risks within the context of both internal policies and international regulatory guidelines. Developing communication tools including reports for audit and inspection metrics and trends, you’ll be responsible for extracting valuable insights from audit data and act as a key point of contact for audits and related documentation, providing strategic support to lead auditors. With a degree or equivalent in a scientific or computing subject, you’ll possess substantial experience of executing and managing audit activities in CSV and GxP quality assurance environments, within the pharmaceutical industry. You will possess an in depth knowledge of Computerized System regulations and guidance applicable to Pharmaceutical systems and infrastructure and also a knowledge of PV and GCP regulations. You’ll enjoy operating in a fast paced, innovative environment with emerging technologies in clinical trials and PV. In return we offer a competitive salary plus the excellent benefits you would expect from a bluechip organisation, including a genuine interest in your development.Roche is an equal opportunity employer.Quality, Quality > Quality Assurance

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