IT Quality Management Director

Introduction to Role

Are you ready to reimagine how a digital AI-enabled enterprise achieves compliance at speed while protecting its license to operate Do you want to lead the quality strategy that enables life-changing medicines to reach patients faster and safer making complex regulations simple actionable and scalable across a global technology landscape

AsIT Quality Management Director you will lead a high-performing team to set the standard for inspection-ready systems and services across the full lifecycle. You will define and embed risk-based modern compliance practices harnessing automation and data to drive better decisions and faster delivery. Reporting to the Senior Director of IT Quality Management you will shape how we manage compliance as new technologies and platforms transform our ways of working ensuring our teams deliver with confidence and clarity.

Accountabilities

• Leadership & Team Development:Lead manage and develop a team of Quality Management professionals (direct and indirect) building future-ready capabilities and a culture of accountability coaching and continuous learning.

• Lifecycle Compliance Ownership:Ensure IT systems and services remain compliant throughout their lifecycle with relevant policies standards and regulations sustaining an inspection-ready posture at all times.

• Inspection Readiness:Provide compliance input to internal management reviews external regulatory inspections and internal audits; ensure high-quality deliverables and evidence are available timely and consistent.

• Risk Management & CAPA:Identify communicate and manage trends in operational compliance risks breaches and issues; drive effective CAPA with clear ownership prioritisation and monitored closure.

• Process Excellence & Simplification:In partnership with quality leadership simplify and standardise internal processes that support inspection readiness ensuring adherence to standards and data principles.

• Lean Digitisation & Automation:Apply LEAN thinking and exploit tools and automation to continuously monitor improve and digitise quality processes services and insights.

• Strategic Compliance Advisory:Use deep industry and compliance expertise to guide programme project and service managers and system owners in risk-based delivery of compliant IT solutions.

• Planning Governance & Insights:Drive accountability through robust planning governance and operational health reporting; interpret quality insights for senior stakeholders to inform decisions and investments.

• Education & Culture:Deliver effective education and training that embeds a proactive compliance culture and protects our license to operate.

• Resource Strategy & Collaboration:Collaborate with quality leadership to align resource capability and capacity with customer needs and technology strategy; ensure changes align to enterprise policies and standards.

• Progressive Impact:In the first 6 months baseline compliance performance establish a unified quality management planning approach and achieve inspection-ready status for priority 1218 months scale automation reduce defects and cycle time and uplift compliance maturity globally.

Essential Skills & Experience

• Knowledge of industry good practice and standards such asISO 9000 ISO 27002 CMMI GAMP GxP ITILandS404 Sarbanes-Oxley
• Extensive experience in multiple areas of quality and compliance within aPharmaceutical or Biotechenvironment
• Leading diverse groups of quality compliance and business stakeholders with varied and often conflicting priorities
• Developing quality compliance and risk strategies and articulating strategic direction for regulated organisations
• Running Quality and Compliance across functions and geographies in large complex and sometimes uncertain IT environments
• Driving risk quality and compliance assurance across multiple aspects of global operations
• Internal auditing and external regulatory inspection management
• Continuous improvement and compliance improvement delivery
• Proven challenge negotiation and influencing capabilities
• StrongChange Managementleadership
• Strong collaboration and relationship-building skills with internal and external stakeholders
• People development and motivation attracting talent and investing in the long-term growth of others
• Constructive and enabling coaching style
• Strong presentation communication and facilitation skills
• Pragmatic decision-making analysing highly complex situations balancing strategic and tactical compliance requirements
• Tenacity challenging the status quo to surface complex issues and drive simple desirable outcomes
• Composure under pressure
• Excellent consulting and business engagement experience capable of translating technical IT concepts for non-technical audiences
• 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 or equivalent experience
• Ability to drive innovation in a Compliance and Quality environment
• External advocacy representing global organisations and collaborating with quality compliance and risk-related industry forums or trade associations

Flexibility & Ways of Working

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform to connect work at pace and challenge perceptions thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca

Here technology and science meet to transform how medicines are discovered developed and delivered. You will work with cutting-edge platforms data and AI alongside diverse experts who move fast simplify the complex and value kindness alongside ambition. We invest in growth through coaching feedback and hands-on experimentation from hackathons to enterprise-scale change so you can shape bold ideas into real outcomes that help patients every day.

Ready

If you are ready to build a modern data-driven compliance capability that accelerates delivery and raises the bar for quality step forward and lead the change.

Date Posted

Closing 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.