IT Quality Management Regional Lead

hace 1 mes


guadalajara, México AstraZeneca A tiempo completo

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 will also optimise utilisation, managing engagement of resources in the most effective way and driving knowledge sharing and innovation.

You will lead a regional team of Quality Management professionals to ensure that our IT systems and services are reliable, and ready for inspections.

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 encouraged 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.

Identify, communicate, and lead trends in operational compliance risks, breaches, and issues, ensuring CAPA to mitigate the risks are discussed and agreed with Collaborators

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 critical thinking around how to run compliance activities in the IT organisation.

Skills required :

  • 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
  • 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, sophisticated and sometimes uncertain IT environments, leading business and IT partners from across the business
  • Continuous improvement / Compliance Improvement
  • Internal auditing and external regulatory inspection management
  • Shown challenge, negotiation & influencing capabilities.
  • Strong Change Management Leadership
  • Tight-knit teamwork and relationship building skill with both internal and external partners, enabling effective enterprise collaboration.
  • Strong people development and motivation skills, attracting talent and investing in long-term development of others.
  • Highly constructive and enabling mentor.
  • Good Presentation, Communication & Facilitation skills
  • Strong leader drives accountability and encourages the organization to do the right thing.
  • 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
  • Relevant External Professional Qualification / Certification / Experience
  • External Advocacy representing global organisations and collaborating with quality / compliance / risk related external industry forums / trade associations.

Ready to make a powerful difference to patients, society and our company? Apply now

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