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IT Quality Management Regional Lead 

Posted date Jul. 26, 2024
Contract type Full time
Job ID R-197433
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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 ID R-197433 Date posted 07/26/2024

Job Title - IT Quality Management Regional Lead

Career Level - F

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. 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, where you are empowered to push the boundaries of science and unleash your ambitious 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.

Typical Accountabilities

As an IT Quality Management Associate Director, you will lead a regional team of Quality Management professionalsto ensure that our IT systems and services are compliant, reliable, and ready for inspections. You will work across the full lifecycle and value chain, delivering compliant projects and servicesreporting to a Director of IT Quality Management. You will be responsible forleading, managing and developing a high performing team of Global IT Quality Management professionals, as well as supporting the broader IT QM leadership team to develop the skills and capabilities for the future across the full QM organisation.

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 expected 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.

  • Utilise effective education and training to help protect our LtO and embed a compliance culture.

  • Own and embed 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.

  • Identify, communicate, and manage trends in operational compliance risks, breaches, and issues, ensuring CAPA to mitigate the risks are discussed and agreed with Stakeholders

  • Drive accountability across IT through effective planning, governance and Operational Healthreporting of key compliance metrics and measures by interpreting Quality insights for senior stakeholders

  • Provide compliance input to the preparation for internal management reviews, external regulatory and internal AZ 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 thinking around how to manage compliance activities in the IT organisation.

  • Utilise your depth of industry and compliance experience to provide direction to programme/project/service managers and system owners, in the development of a risk-based approach for the delivery of compliant IT solutions.

  • Collaborate closely with the QM LT to ensure the provision of appropriate QM resource capability and capacityin line with customer expectations, IT strategy and the needs of AZ.

  • Ensure capability within the team to deliver high quality IT QM project and system deliverables to support external regulatory inspections.

  • Work with the wider Quality Management team to ensure changes to processes and accountabilities align to, and are compatible with, the AZ IT Policies and Standards

Essential skills and Experience

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

Leading diverse groups of quality, compliance, and business stakeholders with varied and often conflicting priorities

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, complex and sometimes uncertain IT environments, leading business and IT partners from across the business

Continuous improvement/Compliance Improvement

Driving risk, quality and compliance assurance across multiple aspects of global operation

Internal auditing and external regulatory inspection management

Proven challenge, negotiation & influencing capabilities.

Strong Change Management Leadership

Strong collaboration and relationship building skill with both internal and external stakeholders, enabling effective enterprise collaboration.

Strong people development and motivation skills, attracting talent and investing in long-term development of others.

Highly constructive and enabling coach.

Good Presentation, Communication & Facilitation skills

Strong leader drives accountability and inspires the organization to do the right thing.

Pragmatic decision making - analyses highly complex situations, assessing risks and balancing strategic and tactical compliance/quality requirements.

Tenacity - challenges the status quo by surfacing challenging and complex issues to get simple and desirable outcomes.

Ability to stay calm under pressure.

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

Broad IT management experience including project or service management.

Familiarity with technical concepts in infrastructure or applications

Relevant External Professional Qualification/Certification/Experience

Ability to drive innovation in a Compliance and Quality environment.

External Advocacy representing global organisations and collaborating with quality/compliance/risk related external industry forums/trade associations.

Key Relationships to reach solutions.

Internal (to AZ or team)

Internal audit & assurance teams/functions.

IT and Business groups supporting the full lifecycle and value chain:

  • Project/Service Management

  • Enterprise/Information Architecture

  • IT Security

  • Other SMEs/Standard Owners

  • System Owners

  • Business Performance

  • Service Introduction and Service Delivery

  • Procurement

  • Business QA

External (to AZ)

  • Third Party Suppliers / External Consultants

  • Regulatory inspectors/auditors

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.

50200039 F ITCQ

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.

Sales Representative Oslo, Norway

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.

Sales Representative California, United States

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.

Sales Representative Petaling Jaya, Malaysia

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.

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