Senior Manager - Quality Management
AstraZeneca India
Date: 1 day ago
City: Chennai, Tamil Nadu
Contract type: Full time

Job Title: Senior Manager - Quality Management
Career Level - E
Introduction to role
Protecting AstraZeneca's license to operate through the delivery and maintenance of compliant innovation, projects, and services. This function comprises 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.
Accountabilities
At AstraZeneca, 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 cutting-edge science with leading digital technology platforms. Join us at this crucial stage of our journey in becoming a digital and data-led enterprise.
Ready to make a difference? Apply today!
Career Level - E
Introduction to role
Protecting AstraZeneca's license to operate through the delivery and maintenance of compliant innovation, projects, and services. This function comprises 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.
Accountabilities
- Accountable for the application of Quality Management processes and services to assure that projects, systems, solutions, and services delivered by IT and their 3rd party suppliers meet AstraZeneca internal and external regulatory requirements.
- Act upon risks and issues to raise compliance and quality levels within IT and the business.
- Support the development and roll-out of training, education, and awareness campaigns for quality and compliance.
- Contribute to the continuous improvement of IT Policies, standards, and procedures.
- Collaborate with system/business process owners to complete or update the Risk Impact Determination (RID) as per the procedure to ensure an understanding of the Regulatory applicability (GxP, SOx, Data Privacy etc.), business, technical, software category, and regulatory risks.
- Review System lifecycle deliverables including RID, specifications, protocols, reports, and the Test Closure Memo with a focus on cGMP impact, validation lifecycle requirements, and quality, and compliance requirements.
- Participate in the review and approval of Exceptions, CAPA, Deviations, Changes, Incidents, and Problems ensuring timely completion and update of System Lifecycle deliverables.
- Collaborate with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes.
- Lead/Participate in the Supplier Assessment to ensure that IT Suppliers meet AstraZeneca Regulatory requirements.
- Act as a QC point of contact for any potential internal and/or regulatory inspection.
- Drive accountability for the completeness, accuracy, and currency of Quality-related data through effective monitoring, tracking, and reporting.
- Process authoring, ownership, lead, quality review, and/or approval as appropriate.
- BA, BSc in Computer or Life Sciences or equivalent, with 3-5 years of experience in the pharmaceutical industry regulatory requirements
- Experience of providing regulatory support including validation of laboratory and business applications
- Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley
- Experience of contributing to implementation of a Quality and/or Compliance strategy with the ability to prioritise and understand the impact of the decisions made
- Experience of operating across business functions and geographies in large, complex and sometimes uncertain IT environments
- Strong communication, influencing and relationship building skills, capable of discussing technical IT terms with a non-technical business audience
- Strong change leadership and team working skills
- Ability to make pragmatic decisions by analysing complex situations and assessing risks
- Concern for impact, analytically minded and 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
- Broad IT management experience including project or service management
- Familiarity with technical concepts in infrastructure or applications
- External qualifications such as ISPE PCC CPIP and ISACA CISM
- Understanding of Lean principles, tools and techniques
At AstraZeneca, 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 cutting-edge science with leading digital technology platforms. Join us at this crucial stage of our journey in becoming a digital and data-led enterprise.
Ready to make a difference? Apply today!
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