Description:

Provide quality and compliance expertise across Development Operations and R&D to ensure that clinical trial systems meet the relevant regulatory electronic system requirements and appropriate quality standards. Coordinate compliance activities globally and/or across the region.    

Accountabilities/Responsibilities:

• Provide advice on clinical system owners for inspection readiness activities
• Drive the development, enhancement and implementation of best practice concerning quality & compliance within R&D particularly for Development Operations systems
• Conduct Quality Reviews for key validation documentation based on a risk-based approach
• Provide targeted training Clinical System Owners and Study teams
• Liaise with other departments and IT Quality personnel to promote consistent validation methodology and requirement applicable to R&D
• 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
• Provide support for computer system related audits and inspections
• Provide computerized system compliance expertise to external partners in the use of external partner computer systems for AZ Clinical trials.
• Maintain an up-to-date knowledge of internal and external regulations pertaining to computer system validation assessing impact on our systems and providing recommendations
• Act as Audit Coordinator for relevant QA audits of clinical systems
• Work with System Owners in addressing Quality Issues and related CAPAs
• Give advice and input to Risk Management activities associated with clinical trial systems

Minimum Requirements:

Education and Experience

• Computing or life science 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.
• Knowledge of clinical and pharmaceutical drug development processes and associated GxPs (especially GCP)
• Extensive Project Management experience including risk management
• Knowledge of principles of Document Management
• Knowledge of principles of Process Management

Skills and Capabilities

• Demonstrated leadership capability
• Demonstrated project management skills
• Strategic thinking
• Conceptual thinking
• Negotiation skills
• Influencing skills
• Ability to manage change
• Coaching and mentoring
• Cultural sensitivity and diplomacy

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.