Compliance & IT Quality Analyst

📌Positions are open to Mexican Citizens and official residents of Mexico.
📍Location: Guadalajara (hybrid)
📌Strong English communication skills required

Must Submit Resume in English

About the AstraZeneca

AstraZeneca is a global, science-led, patient-focused pharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At Astra Zeneca, we’re dedicated to being a Great Place to work!

Job Description

Are you an IT Quality guide with a strong background in the pharmaceutical industry? Do you have a passion for ensuring excellence in quality standards and processes? Would you like to apply your expertise to drive impactful quality initiatives across global teams in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!

Accountabilities

• Responsible for the application of Quality Management Processes and Services to assure that projects, systems, solutions and services delivered by IT and their 3rd party suppliers meet AZ internal and external regulatory requirements.
• Act upon risks and issues to raise compliance and quality levels within IT and the business.
• Collaborates with system/business process owner to complete or update the Risk Impact Determination (RID) as per the procedure to ensure an understanding of the Regulatory applicability (GxP, SOx, Data Privacy etc.), business, technical, software category, and regulatory risks.
• Review of System lifecycle deliverables including RID, specifications, protocols, reports, and the Test Closure Memo with a focus on cGMP impact, validation lifecycle requirements, and quality, and compliance requirements.
• Participate in the review and approval of changes, incidents and problems ensuring completion and update of System Lifecycle deliverables.
• Collaborates with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
• Participates in the Supplier Assessment to ensure that IT Suppliers meet AZ Regulatory requirements.
• Act as a Quality Point of Contact for any potential internal and/or regulatory inspection.

Requirements

• IT bachelor’s degree or IT Background: Required experience in quality process implementation, internal audits, and supplier assessments.
• Strong Interpersonal Skills: Proficient in English with excellent influencing and relationship-building skills, capable of discussing technical IT terms with a non-technical business audience.
• Decision-Making Ability: Shown capability to make pragmatic decisions by analysing sophisticated situations, assessing risks, and stabilizing strategic and tactical compliance/quality requirements.
• Project-Level Quality Planning: Conceptual and practical knowledge of quality models and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, SoX (Sarbanes-Oxley), and Lean/Six Sigma.
• Software Engineering and Project Management: Understanding of software engineering and basic project management principles with a focus on metrics analysis and efficiency improvement through tools and automation.
• Cross-Functional Experience: Experience operating across business functions and geographies in large, sophisticated, and sometimes uncertain IT environments.
• Change Leadership and Partnership: Strong skills in change leadership and effective team partnership.

Desirable

• Regulatory Support Experience: Ability to provide regulatory support, including the validation of laboratory and business applications.
• IT Management Experience: Broad experience in IT management, including project and service management.
• Technical Familiarity: Familiar with technical concepts related to infrastructure and applications.
• External Qualifications: Possession of external certifications such as ISPE PCC CPIP and ISACA CISM.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being daring - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking innovative methods and bringing unexpected teams together.

So, what’s next!

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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 parental 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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Expectation of working in the office 3 days a week statement

When we put unexpected teams in the same room, we ignite ambitious thinking with the power to inspire-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!!!