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IT Quality Management Regional Lead

Location Zapopan, Jalisco, Mexico Job ID R-195819 Date posted 04/07/2024

At AstraZeneca, we're dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and ignite your bold 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.

You will lead a regional team of Quality Management professionalsto 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.

When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.

Why AstraZeneca?
At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit.

Join us in our mission to find solutions to global healthcare and sustainability challenges. Be part of an environment where questioning minds never settle until new insights are uncovered that challenge convention. Acting with vitality, you’ll be empowered to take thoughtful risks to push the boundaries. Committed to making the right choices to win, spotting opportunities and developing our resilience to tackle sophisticated challenges.

When we put unexpected teams in the same room, we ignite ambitious thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and bold world.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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

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.

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