This position is no longer open for applications

Business Quality Manager - Enablement

Description:

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.    

Accountabilities/Responsibilities:

• 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
• Provide coaching/act as a mentor to Clinical System Owners and Study teams
• 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
• Provide support for computer system related audits and inspections
• Provide Training to Clinical Operations Personnel involved in Computerized System Lifecycle Management activities.
• Act as Customer Quality Manager in key system development projects
• Provide computerised 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

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. 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
• Knowledge of principles of Document Management
• Knowledge of principles of Process Management

Skills and Capabilities

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

Next step, Please apply before February 11th!

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.