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IT Quality Management Regional Lead 

Location Chennai, Tamil Nadu, India Job ID R-197433 Date posted 09/05/2024

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 Management 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 professionalsto 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 servicesreporting to a Director of IT Quality Management. You will be responsible forleading, 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:

  • Ensure 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 Healthreporting 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 capacityin 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 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:

  • Project/Service Management

  • Enterprise/Information Architecture

  • IT Security

  • Other SMEs/Standard Owners

  • System Owners

  • Business Performance

  • Service Introduction and Service Delivery

  • Procurement

  • Business QA

External (to AZ)

  • Third Party Suppliers / External Consultants

  • Regulatory inspectors/auditors

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.

50200039 F ITCQ

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.