Senior IT Quality Manager
JOB TITLE: Senior IT Quality Manager
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!
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 AZ license to operate through delivery and maintenance of compliant innovation, projects, and services.
This function comprises IT Quality Management professionals that understand AZs business processes and are experts at integrating business appropriate risk management techniques.
This function will also consult and educate business and the 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.
The main responsibilities of the role are to:
Develop, implement, manage, and govern key IT Compliance Processes (Periodic Review, CAPA, Supplier Assessment and Supplier Re-assessment) roadmap.
Assess and approve the IT Periodic Review, System Assessment & Supplier Assessment plans and reports, ensuring quality deliverables and timely closure of CAPAs.
Lead the development and rollout of IT Periodic Review, System Assessment & Supplier Assessment training, education, and awareness campaigns.
Responsible for the continuous monitoring, improvement, and digitisation through applying LEAN thinking and techniques, exploiting tools and automation to drive standardization and adherence to IT Compliance processes.
Function as an SME for IT Change Management, Periodic Reviews, CAPAs & Deviations, System Assessments and Supplier Assessments & Supplier Re-assessments
Identify, manage, and communicate trends in operational compliance risks, breaches, area of improvements with stakeholders.
Drive accountability across IT through effective planning, governance and TIER reporting of key compliance metrics and measures.
Ability to think, develop, implement, and review preventive and detective controls around key IT compliance processes.
Monitor and assess the effectiveness of compliance controls and make recommendations for improvements.
Apply specialist knowledge to support strategic thinking around how to manage compliance activities in the IT organisation.
Provide compliance input to the preparation for external regulatory and internal AZ inspections as required.
Education, Qualifications, Skills and Experience
Masters in computer or Life Sciences or equivalent, with significant experience within the pharmaceutical industry regulatory requirements
Exposure to ServiceNow, Microsoft Power BI, Power Automate and RPA tools
Experience of 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 and ITIL
Experience of operating across business functions and geographies in large, complex and sometimes uncertain IT environments
Strong compliance experience/expertise
Skills and Capabilities
Excellent communication, presentation, influencing, and relationship building skills, capable of interpreting and discussing technical IT terms with a non-technical business audience
Ability to make pragmatic decisions by analysing highly complex/time-critical situations, assessing risks and stabilising strategic and tactical 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
Strong change leadership and team working skills
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.
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 authorisation and employment eligibility verification requirements.