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Senior Specialist, Risk Based Quality Management

Posted date Jun. 29, 2026
Contract type Full time
Job ID R-255491
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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-255491 Date posted 06/29/2026 Job Title: Senior Specialist, Risk-Based Quality Management

Introduction to role:

Ready to turn data into early signals that protect patients and raise the quality bar across clinical trials? Do you see patterns in complex clinical data and enjoy guiding teams to act on them? If you’re excited by data, collaboration, and patient impact, we welcome your application—whether your path has been traditional or non-linear.

As Senior Specialist, Risk-Based Quality Management, you will deliver centralized monitoring for assigned studies and ensure full alignment with ICH-GCP R2 and our RbQM framework. You will partner early with global and local study teams, and with Centralized Monitoring Clinical Data Scientists, to set requirements, coordinate delivery, and translate insights into decisive actions that safeguard trial integrity and patient safety. In an environment where digital, data science and AI fuel decision-making from lab to clinic, your work will surface critical-to-quality signals that reduce risk and help promising medicines reach patients sooner.

You will shape how studies are monitored, lead cross-functional CtQ reviews, and strengthen risk management plans—building scalable practices that influence not only individual studies but how we run trials across our portfolio. We provide supportive onboarding, training, and mentorship to help you succeed.

Accountabilities:

  • Centralized Monitoring Leadership: Lead and coordinate CM and RbQM deliverables for assigned studies, from requirement definition through execution oversight, ensuring compliance with ICH-GCP R2 and the RbQM framework to protect patient safety and trial integrity.
  • Subject Matter Expertise and Enablement: Serve as a subject matter expert and provide accessible guidance and training on CM functionalities and outputs to global and local study teams and other stakeholders, enabling faster, better-informed decisions.
  • Continuous Improvement: Identify and drive improvements to CM/RbQM processes to promote quality, efficiency, and continuous learning, with measurable gains in signal detection and operational focus.
  • Ensure CtQ factors are monitored through centralized monitoring following the Coordinated Quality Risk Management Plan (IQRMP) and study monitoring plans. Review CtQ data regularly to identify trends, potential risks, and systemic issues. Facilitate CtQ data review meetings with global study teams and share insights with local and global collaborators.
  • Study Quality Risk Management Plan Support: Support—and when appropriate lead, under guidance—activities related to the Study Quality Risk Management Plan (SQRMP), ensuring risks are proactively identified, prioritized, and mitigated.
  • Delivery and Collaboration: Lead delivery of specific tasks within assigned studies or CM initiatives in collaboration with CM colleagues, demonstrating accountability for timelines, quality, and inclusive engagement with collaborators.
  • Advocacy and Cross-Functional Influence: Act as an advocate for centralized monitoring in cross-functional organizational activities, elevating adoption of data-driven monitoring and embedding RbQM principles across teams.

Essential Skills/Experience:

  • Bachelor’s degree (or equivalent experience) in Life Sciences or a related field
  • At least 2 years of experience in the biotech, pharmaceutical, or CRO industry (experience gained through a variety of career paths, including career breaks, military service, caregiving, or volunteering, is valued)
  • Working knowledge of clinical research and pharmaceutical drug development processes
  • Understanding of Risk-Based Monitoring (RBM), Risk-Based Quality Management (RbQM), and centralized monitoring methodologies and tools
  • Strong analytical skills, including experience interpreting data trends, graphs, and charts
  • Awareness of GCP and applicable regulatory requirements related to RBM/RbQM
  • Project and risk management capabilities
  • Effective communication and interpersonal skills, with proficiency in written and spoken English
  • Ability to collaborate in diverse environments with a distributed team

Desirable Skills/Experience:

  • Experience in an RbM/CM-related role
  • Experience organizing or coordinating team activities
  • Experience engaging with senior collaborators
  • Demonstrated ability to contribute to complex, cross-functional initiatives

Why AstraZeneca:Join an organization where scientists, data experts, and clinicians come together to turn signals into decisions that build development. We combine advanced analytics, AI and digital tools with deep biological insight to pursue treatments that prevent, modify and even cure complex diseases. You will strengthen a high-ambition pipeline while learning from patients and partners across industry and academia, working in an environment that values kindness alongside ambition and puts unexpected teams in the same room to unleash bold thinking—so your contribution reaches far beyond a single study and into the lives of people worldwide.

We are committed to building an inclusive and equitable workplace where everyone can thrive. We welcome and encourage candidates of all backgrounds, perspectives, and abilities. Flexible and hybrid working options are available depending on role and location, and we provide reasonable adjustments throughout the recruitment process and employment to support accessibility.

Call to Action:Take the next step to lead risk-based quality that protects patients and speeds development—let your expertise turn insight into impact. If you’re excited by this role but don’t meet every requirement, we still encourage you to apply; your skills and potential may be a great fit. If you need reasonable adjustments during the application or interview process, please let us know.

Date Posted

29-Jun-2026

Closing Date

11-Jul-2026

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.

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 our people.