Job Description

Job Title: QA Advisor - Global Business ServicesCareer level - CIntroduction to roleAstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients by delivering 20 new medicines by 2030. This role is critical in contributing to AZxe2x80x99s long-term ambition. Global Business Services (GBS) is growing to support critical functions across the whole enterprise. This role will be specifically focused on defining and delivering GBS opportunities within the R&D areas of the business. GBS is enhancing its customer focus by establishing Research & Development (R&D) Services to improve alignment and strengthen our relationships with SET areas. R&D Services is a key element of the GBS Bold Ambition, driving our vision to enable AstraZeneca to change and grow at speed. Between now and 2030, 10 new R&D capabilities are to be established, ensuring that GBS can offer the broad range of services required to support AZ ambitions.The successful candidate should be an experienced Patient Safety or Quality professional looking to join a corporate patient safety team as a Patient Safety Quality Advisor. The role will play an integral part in supporting the Patient Safety and Quality Team in the provision of safety and quality services to our Global Marketing Companies, in accordance with the clientxe2x80x99s Patient Safety objectives and quality plan. This will include supporting Leadership Teams to proactively manage quality, promote the highest level of patient safety, and ensure they are fully informed of all quality, patient safety, and risk activity across AstraZenecaxe2x80x99s global teams. This role is crucial in ensuring timely and accurate quality and compliance from our Bangalore hub, contributing to AZxe2x80x99s overall global pharmacovigilance efforts and ultimately supporting patient safety worldwide.Accountabilities

• Support the efficient processing and reporting of adverse event cases within regulatory timelines
• Implement and maintain standardised operating procedures (SOPs) for case intake and processing, ensuring consistency with global pharmacovigilance practices
• Support with the preparation, review, and approval of quality-related documentation, including SOPs, batch records, and validation protocols, ensuring accuracy and compliance
• Work with tools to monitor compliance, quality metrics, and key performance indicators (KPIs) for global PV processes, license partners, and vendors. Ensure feedback and trend analysis to support AstraZeneca continuous improvement.
• Support internal assessments, external audits, and regulatory inspections, and drive best practices for audit and inspection management in collaboration with the clientxe2x80x99s Quality Assurance teams.
• Lead investigations into quality issues, deviations, and non-conformances, determining root-cause and implementing Corrective and Preventative Actions
• Respond to Corrective & Preventive Actions and deviation processes, provide support and guidance on development and implementation, track progress, collect evidence, and coordinate effectiveness checks.
• Proactively support internal training programs related to audit/inspection readiness, compliance, and quality performance indicators, ensuring alignment across global PV teams and affiliates.
• Support data governance initiatives to ensure high-quality data for decision-making, assess downstream implications of data activities, and align ongoing initiatives with compliance requirements.
• Ensure compliance with global regulatory requirements, including timely submission of appropriate Regulatory Reports to relevant authorities
• Serve as a subject matter expert during audits and inspections related to case intake processes within the hub
• Contribute to the development and optimisation of global patient safety processes, systems, and tools, including automation solutions
• Stay updated on regional and global pharmacovigilance regulations for those MCs supported by the hub, ensuring that necessary changes are implemented to maintain compliance
• Self-serve training and development of GBS quality and compliance knowledge and skills within the hub.

Essential Skills/Experience

• BA or BS degree or equivalent
• Experience in the pharmaceutical, biotechnology, or related industry
• Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools
• Strong background in Pharmacovigilance, Regulatory Affairs, or Safety Quality Assurance, with expertise in quality system standards that impact multiple departments
• Knowledge of global safety regulations for both marketed and investigational products
• Exceptional attention to detail and commitment to maintaining high-quality standards in case processing and reporting
• Ability to work in a fast-paced environment, manage multiple priorities, and meet tight deadlines
• Strong analytical and problem-solving skills
• Excellent communication skills, both written and verbal, with the ability to interact effectively with internal and external stakeholders across different regions
• Ability to work in a team environment / works collaboratively

Desirable Skills/Experience

• Knowledge of global and regional pharmacovigilance regulations
• Track record in managing and optimising Patient Safety processes
• Proficiency in safety databases, ideally Argus, and case management systems
• Proven experience in supporting projects within a highly matrixed, multicultural global setting, demonstrating facilitation, problem-solving, and quality and compliance resolution skills.
• Solid understanding of PV and Clinical Research processes, including their interfaces and contributions to the overall PV system.

When we put unexpected teams in the same room, we unleash 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 unique and ambitious world.We couple technology with an inclusive mindset to cross international boundaries and develop a leading ecosystem. A diverse group, we work in cross-functional teams at scale, bringing together the best minds from across the globe to uncover new solutions. Here we think holistically about how to apply technology, building partnerships inside and out. We drive simplicity and efficiencies to make a real difference.Ready to make an impact? Apply now!Date Posted 17-Apr-2025Closing Date 26-Apr-2025AstraZeneca 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.

AstraZeneca