AstraZeneca
IT Quality Management Regional Lead
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Job Description
- Req#: R-197433
E nsure that all IT systems used by sites remain compliant throughout their lifecycle , with the relevant compliance policies , standards and government regulations.
Drive and deliver improvements in our Compliance performance through Lean and automation to continuously improve Quality Management services.
Utilise effective education and training to help protect our LtO and embed a compliance culture.
Own and embed 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 .
Identify , communicate, and manage trends in operational compliance risks, breaches, and issues, ensuring CAPA to mitigate the risks are discussed and agreed with Stakeholders
Drive accountability across IT through effective planning, governance and Operational Health reporting of key c ompliance metrics and measures by interpreting Quality insights for senior stakeholders
Provide compliance input to the preparation for internal management reviews, external regulatory and internal AZ inspections as required .
Drive the continuous monitoring, improvement and digitisation of our processes, services and tools, through applying LEAN thinking and techniques, and exploiting tools and automation.
Apply specialist knowledge to support strategic thinking around how to manage compliance activities in the IT organisation.
Utilise your depth of industry and compliance experience to provide direction to programme/project /service managers and system owners , in the development of a risk-based approach for the delivery of compliant IT solutions.
Collaborate closely with the QM LT to ensure the provision of appropriate QM resource capability and capacity in line with customer expectations, IT strategy and the needs of AZ.
Ensure capability within the team to deliver high quality IT QM project and system deliverables to support external regulatory inspections.
Work with the wider Quality Management team to ensure changes to processes and accountabilities align to, and are compatible with, the AZ IT Policies and Standards
Project /Service Management
Enterprise/Information Architecture
IT Security
Other SMEs/Standard Owners
System Owners
Business Performance
Service Introduction and Service Delivery
Procurement
Business QA
Third Party Suppliers / External Consultants
Regulatory inspectors/auditors
About the company
AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England.
Job Title - IT Quality Management Regional Lead
Career Level - F
AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. 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, where you are empowered to push the boundaries of science and unleash your ambitious spirit. There’s no better place to make a difference to patients, society and the planet.
As an IT Quality Mana gement Associate Director , you’ll work in the IT Quality & Compliance team of the Strategy, Performance & Quality Function in Global IT. This role is crucial to accelerating our compliance efforts as we integrate new technologies , like AI, that require a fundamental rethinking of compliance capabilities, frameworks, and delivery mechanisms to ensure all IT projects and services achieve compliance . You will also optimise utilisation, managing engagement of resources in the most effective way and driving knowledge sharing and innovation.
Typical Accountabilities
As an IT Quality Management Associate Director, you will lead a regional team of Quality Management professionals to ensure that our IT systems and services are compliant, reliable, and ready for inspection s . You will work across the full lifecycle and value chain, delivering compliant projects and services r eporting to a Director of IT Quality Management . You will be responsible for leading, managing and developing a high performing team of Global IT Quality Management professionals, as well as supporting the broader IT QM leadership team to develop the skills and capabilities for the future across the full QM organisation.
In collaboration with the QM LT, you will drive excellence and simplification in the design of our internal processes for supporting inspection readiness, ensuring adherence to standards and data principles .
Using initiative and a self-driven approach to identify and deliver continuous improvement opportunities, the lead will be expected to:
Essential skills and Experience
Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP , ITIL, S404 Sarbanes Oxley
Extensive experience in multiple areas of quality and compliance within a Pharmaceutical/Biotech environment
Leading diverse groups of quality, compliance, and business stakeholders with varied and often conflicting priorities
Developing quality, compliance and risk strategies and articulating the strategic direction for regulated organisations
Experience of running Quality and Compliance across functions and geographies in large, complex and sometimes uncertain IT environments, leading business and IT partners from across the business
Continuous improvement/Compliance Improvement
Driving risk, quality and compliance assurance across multiple aspects of global operation
Internal auditing and external regulatory inspection management
Proven challenge, negotiation & influencing capabilities.
Strong Change Management Leadership
Strong collaboration and relationship building skill with both internal and external stakeholders, enabling effective enterprise collaboration.
Strong people development and motivation skills, attracting talent and investing in long-term development of others.
Highly constructive and enabling coach.
Good Presentation, Communication & Facilitation skills
Strong leader drives accountability and inspires the organization to do the right thing.
Pragmatic decision making - analyses highly complex situations, assessing risks and balancing strategic and tactical compliance/quality requirements.
Tenacity - challenges the status quo by surfacing challenging and complex issues to get simple and desirable outcomes.
Ability to stay calm under pressure.
Excellent consulting and business engagement experience, capable of discussing technical IT terms with a non-technical business audience.
A self-starter with high levels of drive, energy, resilience, and a desire for professional excellence
Desirable Skills/Experience:
Design and implementation of Quality Management Systems as integral to an overall Business System
Broad IT management experience including project or service management.
Familiarity with technical concepts in infrastructure or applications
Relevant External Professional Qualification/Certification/Experience
Ability to drive innovation in a Compliance and Quality environment.
External Advocacy representing global organisations and collaborating with quality/compliance/risk related external industry forums/trade associations.
Key Relationships to reach solutions.
Internal (to AZ or team)
Internal audit & assurance teams/functions.
IT and Business groups supporting the full lifecycle and value chain :
External (to AZ)
Date Posted
22-Apr-2024Closing 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.