Your new company
An exciting opportunity has arisen for a Business Quality Manager to join a leading pharmaceutical company based in Warsaw.
Work place: Mokotów
Function: Clinical Operations
Local Reports To: Group Manager, Enablement
Your new role
As a Business Quality Manager your main responsibilities will include: Provide leadership and direction in the provision of Clinical Systems quality and compliance expertise across Clinical Operations to ensure that Clinical systems meet the relevant regulatory system requirements and appropriate quality standards. Coordinate compliance activities globally and/or across the region. Provide support to Clinical system owners for inspection readiness activities. Drive the development, enhancement and implementation of best practice concerning Clinical Systems Quality & Compliance within Clinical Operations. Liaise with other departments and IS Quality & Compliance personnel to promote a consistent approach. Provide guidance to stakeholders in the planning and delivery of study-specific system validation activities including user acceptance testing, production and archiving of all computer system and study set up validation documentation
What you'll need to succeed
We are looking for a candidate with Computing or Life Science University degree, or equivalent . Extensive experience in Validation of computerised systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc, and knowledge of regulatory (GxP, SOX etc) requirements for computerised systems and infrastructure. Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment. This should have involved the development of procedures (SOPs) and/or processes, and carrying out audits to monitor compliance with defined standards. Knowledge of clinical and pharmaceutical drug development processes and associated GxP. Extensive Project Management experience including risk management. Fluent English is a mandatory.
What you'll get in return
As well as a competitive market salary, you will be encouraged to develop. The company as a whole is friendly and sociable. Our client offers employment contract plus a benefits package. It is possible to work on a home-office 4 days per month.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
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