Job Description

ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the worlds most serious disease. But were more than one of the worlds leading pharmaceutical companies. At AstraZeneca were dedicated to being a Great Place to Work.
ABOUT OUR IT TEAM Its a dynamic and results-oriented environment to work in but thats why we like it. There are countless opportunities to learn and grow, whether thats exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.
ABOUT THE ROLE Protecting AZs license to operate through industry leading delivery and maintenance of world class compliant innovation, projects and services.
This function comprises forward thinking IT Quality Management professionals that understand the evolving external regulatory landscape, AZs internal business processes and are experts at integrating business appropriate risk management techniques.
This function will also consult and educate the business and broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities.
The function is truly global in scale with resources in Asia, EU, North America and South America supporting a broad stakeholder community.

The IT Quality Management IT Quality Analyst (QA) BAU will be expected to work as part of a team as well as using their own functional knowledge to provide technical guidance. The role is responsible for understanding and applying regulatory compliance policies and standards. Using a risk-based approach, they will proactively engage and support the delivery and maintenance of compliant services.

Using initiative and a self-driven approach to contribute towards effective operation, the IT QA will be expected to:
Support compliance activities throughout BAU processes and underpinning tools (e.g. Incident, Problem, Change)

Support collaboration and adoption of the IT QMF key compliance processes globally

Support compliance issue management processes ensuring that organisational and supplier compliance issues are identified, assessed, and resolved in support of AZ's license to operate

Utilise the quality management planning approach and processes ensuring that organisational and supplier compliance risks are identified, assessed, and mitigated in support of AZ's license to operate

Support Lean maturity of the internal processes owned by the QM team

Work with Subject Matter Experts (SMEs) and peers to identify compliance activity opportunities over processes and underpinning tools to drive value and simplification

Actively contribute towards the overall planning, governance and Tier reporting of key metrics and measures

Support the delivery of integrated strategies for Lean, Tools, Automation, Digital and AI

The role is responsible for proactive IT and business engagement to support delivery of compliance activities in the IT organisation. Applying specialist knowledge to ensure Compliance & IT Quality deliverables are aligned with regulatory requirements, customer expectations and IT strategy and meet the needs of AZ.
Helping to protect AZs license to operate by embedding a quality and compliance culture through promotion of education and training.
The role works closely with representatives across IT functions and Business Technology Groups (BTGs), managing risks and issues to pro-actively strive to increase the levels of quality and compliance across IT.

As part of a high performing team of Global IT Quality Management professionals, the IT QA will actively engage in life-long-learning and continuous professional development, and adoption of key collaboration practices, team-work and behaviours.

Typical Accountabilities
Education, Qualifications, Skills and Experience

Essential
Knowledge of providing regulatory guidance and support towards the ongoing maintenance of compliant services

Experience in performing operational Quality & Compliance BAU support

Knowledge and experience of working with/providing regulatory support including computerised system validation/assurance activities

Knowledge on GxP, 21CFRpart11, GAMP

Experience of operating in large IT environments

Desirable
Familiarity with technical concepts in infrastructure or applications

Understanding of Lean principles, tools and techniques

Knowledge of emerging regulatory/digital trends and risks affecting the pharmaceutical industry

Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, , GxP, ITIL, S404 Sarbanes-Oxley

Skills and Capabilities
Essential
Good communication, influencing and relationship building skills, capable of communicating written and verbally at all levels of the organisation, and discussing technical IT terms with a non-technical business audience

Good team working skills

Concern for impact, analytically minded and able to prioritise and plan using initiative

High levels of drive, energy, resilience and a desire for professional excellence

Ability to hold self and others accountable for actions

Desirable
An ability to work effectively in a matrix organisation
Education: Any Graduate
Industry: Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial

Skills Required