IT Quality Management Regional Lead

hace 3 semanas


Guadalajara, México AstraZeneca A tiempo completo

**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 Mana**gement **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 professionals** **to ensure** that our IT systems and services are reliable, and ready for inspection**s. **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**:

- ** E**nsure 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**:
**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



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