Director-IT Quality Management

Job Title: Director- IT Quality Management

Career Level: F

Introduction to role

AstraZeneca functions as a global BioPharmaceutical business dedicated to discovering, developing, and commercializing prescription medicines for severe diseases on a global scale. But we re more than one of the world s leading pharmaceutical companies. At AstraZeneca, were dedicated to empowering you to push the boundaries of science and unleash your high-reaching spirit. There s no better place to make a difference to patients, society, and the planet.

As an IT Quality Management 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.

Accountabilities

As an IT Quality Management Director, you will lead a team of Quality Management professionals to ensure that our IT systems and services are compliant, reliable, and ready for inspections. You will work across the full lifecycle and value chain, delivering compliant projects and services reporting to the Senior Director of IT Quality Management. You will be responsible for leading, handling 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 hard-working approach to identify and deliver continuous improvement opportunities, the lead will be expected to:

- Ensure that IT systems 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 interpersonal and supplier compliance risks are identified, assessed, and mitigated in support of AZs 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 compliance 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.

Essential Skills/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.