CAREER LEVEL: E
Leverage technology to impact patients and ultimately save lives
Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!
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 world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.
ABOUT OUR IT TEAM
It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s 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 Project Quality Manager (PQM) will use their pharmaceutical regulatory compliance experience and intelligence to support and deliver an integrated IT QM strategy. 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 of compliant projects and programmes. The role can represent AstraZeneca on external industry forums.
Using initiative and a self-driven approach to identify and deliver continuous improvement opportunities, the IT PQM will be expected to:
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 you and/or the Projects lead/team
Influence compliance activities over project delivery methodologies (e.g. Agile, Waterfall), processes and underpinning tools to drive value and simplification
Actively contribute towards the overall planning, governance and Tier reporting of key metrics and measures
Utilise Quality insights to maximise performance, productivity and adherence to our processes, and to drive value for peers and partners
Support the development and delivery of integrated strategies for Lean, Tools, Automation, Digital and AI
The role is responsible for proactive IT and business engagement to support management and 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 to meet the needs of AZ.
Helping to protect AZs license to operate by embedding a quality and compliance culture through development and delivery of education and training.
The role works closely with representatives across IT functions and BTGs, acting upon risks and issues to pro-actively strive to increase the levels of quality and compliance across IT with forward thinking concepts to support the business desire to implement new technologies and to pre-empt the evolving regulatory move towards CSA.
The role will predominately work with the Operations business in support of their programmes to digitise key business processes such as Continuous Direct Compression and Advanced Process Control along with the Clinical Supply Chain Agile Business Strategy.
As part of a hard-working team of Global IT Quality Management professionals, the IT PQM will actively engage in life-long-learning and continuous professional development. This will include supporting the development of skills and capabilities across the full Quality Management organisation and adoption of key collaboration practices and behaviours.
Typical Accountabilities
Education, Qualifications, Skills and Experience
Essential
BA, BSc in Computer or Life Sciences or equivalent, with 3-5 years of experience in the pharmaceutical industry regulatory requirements
Knowledge and experience of working with/providing regulatory support including computerised system validation/assurance activities.
Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley
Experience of contributing to implementation of a Quality and/or Compliance strategy with the ability to prioritise and understand the impact of the decisions made
Experience of operating across business functions and geographies in large, complex and evolving IT environments
Knowledge of emerging regulatory/digital trends and risks affecting the pharmaceutical industry
Desirable
Broad IT management experience including project or service management
Familiarity with technical concepts in infrastructure or applications
Understanding of Lean principles, tools and techniques
Skills and Capabilities
Essential
Strong communication, influencing and relationship building skills, capable of discussing technical IT terms with a non-technical business audience
Strong change leadership and team working skills
Ability to make pragmatic decisions by analysing complex/time-critical situations, assessing risks and identifying mitigating compliance/quality requirements
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
WHY JOIN US ?
We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.
We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.
SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
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