Why choose AstraZeneca India?
Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare.
The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports.
Who do we look for?
Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.
Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.
Success Profile
Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.
Tech innovators
Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives.
Ownership takers
If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it.
Challenge seekers
Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks.
Proactive collaborators
Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best.
Responsibilities
Job Title: IT Quality Management Lead
Career Level - F
Introduction to role
Protecting AstraZeneca's license to operate through the delivery and maintenance of compliant innovation, projects, and services. This function comprises IT Quality Management professionals who understand AstraZeneca's business processes and are experts at integrating business-appropriate risk management techniques. This function will also consult and educate the business and the 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.
Accountabilities
Specialise in Quality and Compliance, supporting the overall strategy for IT Quality Management to ensure that systems and services remain compliant in line with changing regulations, sanctions, the broader AstraZeneca IT Strategy, and AstraZeneca Corporate Strategy.
Utilise your depth of industry experience to set direction for operational performance, metrics, and delivery of IT Quality Management services for International (e.g., Regional/Site inspection readiness and support, local project implementations).
Establish a forward-looking view of new systems needing sanctions assessment, particularly those related to emerging technologies like AI, and provide support throughout the sanctions assessment process.
Follow up on IT implications when there are changes to sanctions to ensure all connection points related to IT are fully up to date and maintained, as required by Global Compliance.
Confirm if IT hardware or software falls under specific legal and technical descriptions and assess whether equipment qualifies for exceptions to regulations.
Apply export control regulations, sanctions, and related compliance requirements to ensure adherence to international trade laws and regulations in the context of quality management.
Structure, interpret, and embed local, regional, or top-level IT and specialist compliance policies, standards, and government guidance and regulations through IT and business engagement.
Drive excellence and simplification in the design of our internal LtO processes ensuring adherence to standards and data principles.
Collaborate closely with the business and IT teams, ensuring an understanding of the areas of GxP, SOx, Data Privacy applicability, and impact to Sites, Technology (Hardware and Software) based on the business process and use.
Ensure that IT systems 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.
Embed compliant practices for AI/ML within local projects and programmes.
Utilise effective education and training to help protect our LtO and embed a compliance culture.
Act as Process owner for key compliance processes responsible for driving Lean maturity of the processes.
Act upon risks and issues to pro-actively strive to increase the levels of quality and compliance across IT.
Identify, communicate, and manage trends in operational compliance risks (including BCP), breaches, and issues, ensuring CAPA to mitigate the risks are discussed and agreed with Stakeholders.
Drive accountability across IT through effective planning, governance, and reporting of key Compliance metrics and measures by interpreting Quality insights for senior team members.
Provide compliance input to the preparation for internal management reviews, external regulatory, and internal AstraZeneca inspections as required.
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 strategic critical thinkingthinking around how to manage compliance activities.
Essential Skills/Experience
BA, BS in Computer or Life Sciences or equivalent, with 5+ years of experience in the pharmaceutical industry regulatory requirements including export control regulations.
Knowledge and experience of working with/providing regulatory support including computerised system validation/assurance activities.
Knowledge and experience of working with industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley.
Experience of operating at senior levels including leading and managing global teams, operating across business functions and geographies in large, complex, and sometimes uncertain IT environments.
Experience in establishing a Quality Management Strategy in Life Sciences environment.
Knowledge of international sanctions and export controls, particularly those impacting IT.
Skills and Capabilities
Excellent communication, influencing, and relationship-building skills capable of interpreting and discussing technical IT terms with a non-technical business audience.
Ability to make pragmatic decisions by analysing highly sophisticated/time-critical situations, assessing risks, and stabilising strategic and tactical compliance/quality requirements.
Concern for impact, analytically minded, 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.
Proven change leadership and team working skills.
Ability to identify, assess, and mitigate IT-related risks, particularly those arising from sanctions and export controls.
Desirable Skills/Experience
Broad IT management experience including project or service management.
Familiarity with technical concepts in infrastructure or applications.
Understanding of Lean principles, tools, and techniques.
When we put unexpected teams in the same room, we ignite 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 outstanding and ambitious world.
AstraZeneca is a place where technology meets science. Our work has a direct impact on patients by transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining powerful science with leading digital technology platforms. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate freely while being supported all the way.
Ready to make an impact? 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.
Reasons to Join
Thomas Mathisen
There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.
Christine Recchio
Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.
Stephanie Ling
There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.
What we offer
We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you.
Lifelong learning
Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still.
Autonomy and reward
Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package.
Health and wellbeing
An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority.
Inclusion and diversity
Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.