Job Title: Quality & Compliance Manager - Global Business Services
Location: [Insert Location Here]
Career Level: D
Introduction to Role: AstraZeneca (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 AZ’s 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.
As the Patient Safety Quality Manager, you will be responsible for developing and maintaining excellence in global PV Quality, Compliance, Audit and Inspection management, Process Improvement, and Data Governance. You will ensure oversight of the PV Quality Management System, maintain inspection readiness, and ensure compliance with worldwide pharmacovigilance regulations. Collaborating with key PV and non-PV stakeholders across AstraZeneca, you will align with company-wide standards, oversee compliance and quality of PV processes, conduct internal audits and deviation investigations, analyse and report on key metrics, and support the client’s continuous improvement plans to establish best-in-class PV practices. This role is crucial in ensuring the timely and accurate quality and compliance from our Bangalore hub, contributing to AZ’s overall global pharmacovigilance efforts and ultimately supporting patient safety worldwide.
Accountabilities:
Quality and Compliance Oversight:
Oversee the daily operations of Quality and Compliance within the Bangalore hub, supporting the efficient processing and reporting of adverse event cases within regulatory timelines.
Lead and manage the Quality and Compliance Advisors, ensuring appropriate guidance, training, and performance management to maintain high-quality standards.
Implement and maintain standardized operating procedures (SOPs) for case intake and processing, ensuring consistency with global pharmacovigilance practices.
Collaborate with other GBS Patient Safety Hub Managers and Directors and the Global Patient Safety (GPS) team to improve processes and share best practices.
Compliance Monitoring:
Control the 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 efforts.
Lead internal assessments, support external audits and regulatory inspections, and implement standard processes for audit and inspection management in collaboration with the client’s Quality Assurance teams.
Corrective & Preventive Actions:
Oversee Corrective & Preventive Actions and deviation processes, providing support and guidance on development and implementation.
Track progress, collect evidence, and coordinate effectiveness checks.
Process Improvement & Data Governance:
Support a drive in continuous process improvements by analyzing audit/inspection findings, identifying quality risks, and leading initiatives to enhance PV compliance and operational efficiency.
Develop and maintain 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 and assess downstream implications of data activities.
Regulatory Compliance & Staffing:
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 optimization 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 necessary changes are implemented to maintain compliance.
Maintain appropriate staffing levels in the hub, and manage the recruitment of new staff where required.
Essential Skills/Experience:
BA or BS degree or equivalent.
Extensive experience in the pharmaceutical, biotechnology, or related industry.
Strong background in Pharmacovigilance, Regulatory Affairs, or Safety Quality Assurance, with expertise in establishing safety quality system standards that impact multiple departments and management levels.
Proven experience in people or project management within a highly matrixed, multicultural global setting.
Deep knowledge of global safety regulations for both marketed and investigational products, along with expertise in process management, standards, training, and IT functions across the pharmaceutical product life cycle.
Solid understanding of PV and Clinical Research processes, including their interfaces and contributions to the overall PV system.
Expertise in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools.
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 collaboratively in a team environment.
Desirable Skills/Experience:
Knowledge of global and regional pharmacovigilance regulations.
Track record in managing and optimizing Patient Safety processes.
Proficiency in safety databases, ideally Argus, and case management systems.
Work Model:
Minimum of three days per week in-office, with flexibility to accommodate individual needs.
About AstraZeneca: AstraZeneca is a place where technology meets science to create life-changing medicines. We empower our teams to innovate using cutting-edge technology platforms combined with data analytics. Our collaborative environment fosters creativity as we work together to push boundaries. With significant investment behind us, we are driving cross-company change that disrupts the industry.
Ready to make an impact? Apply now!
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