AstraZeneca Looking for Senior Analyst – IT Quality Management/Associate Quality Manager at Chennai, Tamil Nadu Full Time

JOB TITLE: SENIOR ANALYST

CAREER LEVEL: D2

Leverage technology to impact patients and ultimately save lives

Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

About astrazeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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 AstraZeneca we’re dedicated to being a Great Place to Work.

About our it team

It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.

About the role

Protecting AZs license to operate through industry leading delivery and maintenance of world class compliant innovation, projects and services.

This function comprises forward thinking IT Quality Management professionals that understand the evolving external regulatory landscape, AZs internal business processes and are experts at integrating business appropriate risk management techniques.

This function will also consult and educate the business and broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities.

The function is truly global in scale with resources in Asia, EU, North America and South America supporting a broad stakeholder community.

The IT Quality Management – Associate Quality Manager (AQM) will be expected to act without direct supervision and use their pharmaceutical regulatory compliance experience and intelligence to support and deliver an integrated IT QM strategy. The role is responsible for understanding and applying regulatory compliance policies and standards. Using a risk-based approach, they will proactively engage and support the delivery of compliant projects and programmes.

Using initiative and a self-driven approach to contribute towards effective operation, the IT AQM will be expected to:

Utilise 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

Support Lean maturity of the internal processes owned by the QM team

Liaise with team leads and peers to identify compliance activity opportunities over processes and underpinning tools to drive value and simplification

Actively contribute towards the overall planning, governance and Tier reporting of key metrics and measures

Support the delivery of integrated strategies for Lean, Tools, Automation, Digital and AI

The role is responsible for proactive IT and business engagement to support delivery of compliance activities in the IT organisation. Applying specialist knowledge to ensure Compliance & IT Quality deliverables are aligned with regulatory requirements, customer expectations and IT strategy and meet the needs of AZ.

Helping to protect AZs license to operate by embedding a quality and compliance culture through promotion of education and training.

The role works closely with representatives across IT functions and BTGs, managing risks and issues to pro-actively strive to increase the levels of quality and compliance across IT.

As part of a high performing team of Global IT Quality Management professionals, the IT AQM will actively engage in life-long-learning and continuous professional development, and adoption of key collaboration practices, team-work and behaviours.

Education, Qualifications, and Experience

Essential

BA, BS in Computer Science, Information Technology or Life Sciences or equivalent, with more than 5 years of experience in the pharmaceutical industry regulatory requirements

Knowledge and experience of working with/providing regulatory support including computerised system validation/assurance activities.

Knowledge of SDLC frameworks, EU GMP Annex 11, US FDA 21 CFR Part 11 compliance

Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley

Experience of operating across business functions and geographies in large IT environments

Desirable

Broad IT management experience including project or service management

Familiarity with technical concepts in infrastructure or applications

Understanding of Lean principles, tools and techniques

Knowledge of emerging regulatory/digital trends and risks affecting the pharmaceutical industry

Knowledge of Enterprise tools like ECMS, Jira X-ray, HP ALM

Skills and Capabilities

Essential

Good communication, influencing and relationship building skills, capable of communicating written and verbally at all levels of the organisation, and discussing technical IT terms with a non-technical business audience

Good change leadership and team working skills

Concern for impact, analytically minded and able to prioritise and plan using initiative

High levels of drive, energy, resilience and a desire for professional excellence

Ability to hold self and others accountable for actions

Desirable

An ability to work effectively in a matrix organization

WHY JOIN US?

We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.